Gulf War Illness Research and the CALL FOR ACTION For Every American that Say They Support Veterans!
Each year Gulf War Veterans who are ill and a couple of well known advocates storm the Hill in DC to literally beg for funding into biomarkers, diagnosis, and treatment for Gulf War Illness. Each year they beg US Representatives and Senators to back Reearch Funding thru the DOD CDMRP(Congressionally Directed Medical Research Program) GWI(Gulf War Illness).
The Committees on Defense Appropriations and Defense Authorizations have not even given them the courtesy of committees hearings to hear directly from them on the needs. Each year a very small group of Senators and Representatives step forward to back the effort. Since somehow in all the wisdom of Washington DC they have labelled this as Earmark legislation and you know how they run from those words in public. This is not Earmark Legislation it does not target benefits to any state or legislative district.
The CDMRP program is an open and competitive program open to all Researchers worldwide to participate. This is a scientific merit review process composed of two review panels. One panel assures that the goals of the program are met ie that it targets biomarker or diagnostic markers and treatment trials for gulf war illness. The other panel does the painstaking review of scientific merit review of each proposal.
Each year these sick gulf war veterans and their few advocates have to be forced to beg for funding that so far has ranged from 5-10 million a year. A total of 15 mil for FY06-08 and then 8 million in FY 09. When 1 in 4 Gulf War Veterans 1990-91 are ill from Gulf War illness, this country needs to give them every resource needed and quit making ill Gulf War Veterans go door to door in DC on the hill to ask/beg for this help.
The answers that will come may well help millions of veterans and civilians that have sufferred from hazardous exposures in the past or in the future. So far 22 scientific studies have been funded. Below is a list of the current 6 studies currently funded and on contract and Gulf War Veterans of 1990-91 are being asked to answer the call to service again and participate in these valuable studies for answers and help not for just themselves but the thousands that are ill. This year the funding requested is a mere 12 million, less than 60 dollars for each veteran affected.
The rest of America needs to hear these veterans that do not want to live on compensation but want medical answers and treatments to hopefully restore a quality of life that might lead them back to productive lives. The rest of America needs to be lending their voices and actions to these veterans’ to demand the attention and funding needed now.
Seeking Study Participants for Gulf War Illness Research
GULF WAR VETERANS ENCOURAGE TO BE INVOLVED NOW
There are currently 6 studies actively recruiting gulf war (90-91)veterans for research into gulf war illness. We encourage gulf war veterans to participate in these studies. Contact individuals are listed. You need to contact them directly. Some of the studies have travel funds some do not. The studies at George Washington in DC are excellent! Many gulf war veterans have given feedback that these people are the best that they have met in understanding our illnesses. Please help us spread the word about these programs! They are listed in full below this introduction.
If you would like to talk about these you may contact me at [email protected]
1. Gulf War Digestive Health Study
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, June 2009
First Received: May 16, 2008 Last Updated: June 24, 2009 History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680836
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, June 2009
First Received: May 16, 2008 Last Updated: June 24, 2009 History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680836
Purpose
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether SBBO is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG veterans.
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether SBBO is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG veterans.
Condition Intervention
Irritable Bowel Syndrome
Drug: Placebo
Drug: Rifaximin
Irritable Bowel Syndrome
Drug: Placebo
Drug: Rifaximin
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans
Resource links provided by NLM:
MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin
U.S. FDA Resources
Drug Information available for: Rifaximin
U.S. FDA Resources
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
•Improvement in IBS Global Improvement Scale. [ Time Frame: once a month for the 6 months following completion of medication ] [ Designated as safety issue: No ]
•Improvement in IBS Global Improvement Scale. [ Time Frame: once a month for the 6 months following completion of medication ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
•Change in Symptom Severity [ Time Frame: 6 months after medication regimine is completed ] [ Designated as safety issue: No ]
•Change in Symptom Severity [ Time Frame: 6 months after medication regimine is completed ] [ Designated as safety issue: No ]
•Change in IBS-QOL Questionnaire [ Time Frame: 1 week after starting the medication, 2 weeks after starting the medication, 1 month after finishing medication, 6 months after finishing medication ] [ Designated as safety issue: No ]
•Change in LBT [ Time Frame: 6 months after completion of medication ] [ Designated as safety issue: No ]
Estimated Enrollment: 140
Study Start Date: October 2007
Estimated Study Completion Date: August 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
These patients do not have IBS. They may be deployed or non-deployed veterans.
2: Active Comparator
These patients have IBS and are receiving the rifaximin. Drug: Rifaximin
550 mg orally two times per day for 14 days
3: Placebo Comparator
These patients have IBS and are receiving the placebo. Drug: Placebo
orally two times per day for 14 days
Study Start Date: October 2007
Estimated Study Completion Date: August 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
These patients do not have IBS. They may be deployed or non-deployed veterans.
2: Active Comparator
These patients have IBS and are receiving the rifaximin. Drug: Rifaximin
550 mg orally two times per day for 14 days
3: Placebo Comparator
These patients have IBS and are receiving the placebo. Drug: Placebo
orally two times per day for 14 days
Detailed Description:
Approximately 700,000 United States military personnel were deployed in the first Persian Gulf (PG) War. Several months after their return, up to 25% of Veterans had persistent symptoms which they suspected were related to their military service in the Gulf. Among the most frequent were gastrointestinal symptoms such as loose stools, excessive gas and abdominal pain. These symptoms are typical of diarrhea-predominant irritable bowel syndrome (IBS). The cause of IBS is not known; speculated mechanisms include altered GI motility, bacterial overgrowth, visceral hypersensitivity and psychological stress. Another proposed mechanism relates to the fact that up to one third of patients with IBS describe the onset of their symptoms following acute gastroenteritis. This is called post-infective IBS (PI-IBS). How acute gastroenteritis leads to persistent GI symptoms of IBS is not known. A limited amount of data suggests that patients with IBS may have an imbalance in their gastrointestinal microflora. Several studies indicate that small bowel bacterial overgrowth is more common in individuals with IBS. Symptoms of SBBO are similar to diarrhea-predominant IBS and include chronic diarrhea, bloating and abdominal pain. More than 50 percent of military personnel developed acute gastroenteritis while on duty in the Gulf. Most of them who reported symptoms of IBS had an acute onset which occurred in association with an episode of acute gastroenteritis during their tour of duty. Other travelers are known to be colonized by new micro-organisms during travel to foreign countries. This acquisition is thought to be related to a change in diet. The natural history of this change in bowel flora, in part, depends on host factors and can persist for months after travel abroad. It seems likely, that PG veterans with persistent diarrhea and a negative work-up for known GI diseases have PI-IBS. No study in the past has evaluated the role of SBBO in causing chronic GI symptoms in PG Veterans.
Approximately 700,000 United States military personnel were deployed in the first Persian Gulf (PG) War. Several months after their return, up to 25% of Veterans had persistent symptoms which they suspected were related to their military service in the Gulf. Among the most frequent were gastrointestinal symptoms such as loose stools, excessive gas and abdominal pain. These symptoms are typical of diarrhea-predominant irritable bowel syndrome (IBS). The cause of IBS is not known; speculated mechanisms include altered GI motility, bacterial overgrowth, visceral hypersensitivity and psychological stress. Another proposed mechanism relates to the fact that up to one third of patients with IBS describe the onset of their symptoms following acute gastroenteritis. This is called post-infective IBS (PI-IBS). How acute gastroenteritis leads to persistent GI symptoms of IBS is not known. A limited amount of data suggests that patients with IBS may have an imbalance in their gastrointestinal microflora. Several studies indicate that small bowel bacterial overgrowth is more common in individuals with IBS. Symptoms of SBBO are similar to diarrhea-predominant IBS and include chronic diarrhea, bloating and abdominal pain. More than 50 percent of military personnel developed acute gastroenteritis while on duty in the Gulf. Most of them who reported symptoms of IBS had an acute onset which occurred in association with an episode of acute gastroenteritis during their tour of duty. Other travelers are known to be colonized by new micro-organisms during travel to foreign countries. This acquisition is thought to be related to a change in diet. The natural history of this change in bowel flora, in part, depends on host factors and can persist for months after travel abroad. It seems likely, that PG veterans with persistent diarrhea and a negative work-up for known GI diseases have PI-IBS. No study in the past has evaluated the role of SBBO in causing chronic GI symptoms in PG Veterans.
Furthermore, soldiers involved in combat are exposed to a highly stressful environment, perhaps making them more susceptible to persistent symptoms. We hypothesize that PG veterans with chronic GI symptoms have symptoms of diarrhea predominant IBS and this is caused by SBBO due to a change in microflora during deployment in the Persian Gulf and that it is predisposed to by the stress of combat. Intestinal microflora, once altered, is known to be relatively stable; once mucosal damage occurs it may become permanent.
Objectives Objective # 1: Estimate the burden of disease due to chronic gastrointestinal illness in PG veterans.
Hypothesis:
i. The prevalence of GI symptoms is high in PG veterans. ii. The prevalence of IBS is higher in veterans who report acute gastroenteritis during the period of deployment.
iii. PG Veterans with IBS have a lower IBS related QOL
Objective # 2: Evaluate whether SBBO is associated with chronic diarrhea in PG veterans.
Hypothesis i. SBBO is more common in PG veterans than non deployed veterans. ii. SBBO is more common in PG veterans with diarrhea-predominant IBS vs. those without.
Objective: # 3: Determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG Veterans.
Hypothesis:
i. Treatment with rifaximin, a non-absorbable antibiotic, will improve symptoms and QOL in Veterans with SBBO.
Eligibility
Ages Eligible for Study: 35 Years to 72 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Inclusion Criteria:
•Men and women age 32-75 years
•Rome III criteria for diarrhea-predominant IBS
•Symptom onset after an apparent episode of acute gastroenteritis
•Symptoms of > 3 months duration
•Normal endoscopic appearance of the colonic mucosa
•Negative markers for celiac disease and inflammatory bowel disease.
•Normal thyroid function and serum calcium levels.
•Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991)
Exclusion Criteria:
•Rome III criteria for diarrhea-predominant IBS
•Symptom onset after an apparent episode of acute gastroenteritis
•Symptoms of > 3 months duration
•Normal endoscopic appearance of the colonic mucosa
•Negative markers for celiac disease and inflammatory bowel disease.
•Normal thyroid function and serum calcium levels.
•Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991)
Exclusion Criteria:
•Clinically significant cardiac, pulmonary, hepatic or renal dysfunction
•History of/or presence of systemic malignancy
•Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e.
Crohns disease or ulcerative colitis)
•History of/or presence of systemic malignancy
•Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e.
Crohns disease or ulcerative colitis)
•Current effects of drug or alcohol abuse
•Investigator perception of patients inability to comply with study protocol
•Unstable psychiatric disease
•Recent change in gastrointestinal medications
•Subjects with a positive pregnancy test
•Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
Contacts and Locations
•Investigator perception of patients inability to comply with study protocol
•Unstable psychiatric disease
•Recent change in gastrointestinal medications
•Subjects with a positive pregnancy test
•Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680836
Contacts
Contact: Rebecca A Campo, PhD MS (801) 582-1565 ext 1993 [email protected]
Contact: Diana Trujillo (801) 582-1565 ext 4840 [email protected]
Contact: Rebecca A Campo, PhD MS (801) 582-1565 ext 1993 [email protected]
Contact: Diana Trujillo (801) 582-1565 ext 4840 [email protected]
Locations
United States, Utah
Division of Epidemiology Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Rebecca A Campo, PhD MS 801-582-1565 ext 1993 [email protected]
Principal Investigator: Ashok K Tuteja, MD MPH
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Ashok K Tuteja, MD MPH Division of Epidemiology
United States, Utah
Division of Epidemiology Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Rebecca A Campo, PhD MS 801-582-1565 ext 1993 [email protected]
Principal Investigator: Ashok K Tuteja, MD MPH
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Ashok K Tuteja, MD MPH Division of Epidemiology
More Information
Publications:
[No authors listed] Self-reported illness and health status among Gulf War veterans. A population-based study. The Iowa Persian Gulf Study Group. JAMA. 1997 Jan 15;277(3):238-45.
Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8.
Sostek MB, Jackson S, Linevsky JK, Schimmel EM, Fincke BG. High prevalence of chronic gastrointestinal symptoms in a National Guard Unit of Persian Gulf veterans. Am J Gastroenterol. 1996 Dec;91(12):2494-7.
[No authors listed] Unexplained illnesses among Desert Storm veterans. A search for causes, treatment, and cooperation. Persian Gulf Veterans Coordinating Board. Arch Intern Med. 1995 Feb 13;155(3):262-8.
Orskov F, Sack RB, Orskov I, Froelich JL. Changing fecal Escherichia coli flora during travel. Eur J Clin Microbiol. 1984 Aug;3(4):306-9.
Hyams KC, Bourgeois AL, Merrell BR, Rozmajzl P, Escamilla J, Thornton SA, Wasserman GM, Burke A, Echeverria P, Green KY, et al. Diarrheal disease during Operation Desert Shield. N Engl J Med. 1991 Nov 14;325(20):1423-8.
Camilleri M. Mechanisms in IBS: something old, something new, something borrowed… Neurogastroenterol Motil. 2005 Jun;17(3):311-6. No abstract available.
Singh VV, Toskes PP. Small Bowel Bacterial Overgrowth: Presentation, Diagnosis, and Treatment. Curr Treat Options Gastroenterol. 2004 Feb;7(1):19-28.
Spiller RC. Postinfectious irritable bowel syndrome. Gastroenterology. 2003 May;124(6):1662-71. Review.
Pimentel M, Chow EJ, Lin HC. Normalization of lactulose breath testing correlates with symptom improvement in irritable bowel syndrome. a double-blind, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):412-9.
Pimentel M, Soffer EE, Chow EJ, Kong Y, Lin HC. Lower frequency of MMC is found in IBS subjects with abnormal lactulose breath test, suggesting bacterial overgrowth. Dig Dis Sci. 2002 Dec;47(12):2639-43.
Pimentel M, Chow EJ, Lin HC. Eradication of small intestinal bacterial overgrowth reduces symptoms of irritable bowel syndrome. Am J Gastroenterol. 2000 Dec;95(12):3503-6.
[No authors listed] Self-reported illness and health status among Gulf War veterans. A population-based study. The Iowa Persian Gulf Study Group. JAMA. 1997 Jan 15;277(3):238-45.
Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8.
Sostek MB, Jackson S, Linevsky JK, Schimmel EM, Fincke BG. High prevalence of chronic gastrointestinal symptoms in a National Guard Unit of Persian Gulf veterans. Am J Gastroenterol. 1996 Dec;91(12):2494-7.
[No authors listed] Unexplained illnesses among Desert Storm veterans. A search for causes, treatment, and cooperation. Persian Gulf Veterans Coordinating Board. Arch Intern Med. 1995 Feb 13;155(3):262-8.
Orskov F, Sack RB, Orskov I, Froelich JL. Changing fecal Escherichia coli flora during travel. Eur J Clin Microbiol. 1984 Aug;3(4):306-9.
Hyams KC, Bourgeois AL, Merrell BR, Rozmajzl P, Escamilla J, Thornton SA, Wasserman GM, Burke A, Echeverria P, Green KY, et al. Diarrheal disease during Operation Desert Shield. N Engl J Med. 1991 Nov 14;325(20):1423-8.
Camilleri M. Mechanisms in IBS: something old, something new, something borrowed… Neurogastroenterol Motil. 2005 Jun;17(3):311-6. No abstract available.
Singh VV, Toskes PP. Small Bowel Bacterial Overgrowth: Presentation, Diagnosis, and Treatment. Curr Treat Options Gastroenterol. 2004 Feb;7(1):19-28.
Spiller RC. Postinfectious irritable bowel syndrome. Gastroenterology. 2003 May;124(6):1662-71. Review.
Pimentel M, Chow EJ, Lin HC. Normalization of lactulose breath testing correlates with symptom improvement in irritable bowel syndrome. a double-blind, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):412-9.
Pimentel M, Soffer EE, Chow EJ, Kong Y, Lin HC. Lower frequency of MMC is found in IBS subjects with abnormal lactulose breath test, suggesting bacterial overgrowth. Dig Dis Sci. 2002 Dec;47(12):2639-43.
Pimentel M, Chow EJ, Lin HC. Eradication of small intestinal bacterial overgrowth reduces symptoms of irritable bowel syndrome. Am J Gastroenterol. 2000 Dec;95(12):3503-6.
Responsible Party: Department of Veterans Affairs ( Tuteja, Ashok – Principal Investigator )
Study ID Numbers: GWRA-014-05F, IRB#16469
Study First Received: May 16, 2008
Last Updated: June 24, 2009
ClinicalTrials.gov Identifier: NCT00680836 History of Changes
Health Authority: United States: Federal Government
Study ID Numbers: GWRA-014-05F, IRB#16469
Study First Received: May 16, 2008
Last Updated: June 24, 2009
ClinicalTrials.gov Identifier: NCT00680836 History of Changes
Health Authority: United States: Federal Government
Keywords provided by Department of Veterans Affairs:
Irritable Bowel Syndrome
Diarrhea
Irritable Bowel Syndrome
Diarrhea
Additional relevant MeSH terms:
Pathologic Processes
Disease
Digestive System Diseases
Gastrointestinal Diseases
Syndrome
Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional
Pathologic Processes
Disease
Digestive System Diseases
Gastrointestinal Diseases
Syndrome
Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional
————————————————————————————————
2. Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
This study is currently recruiting participants.
Verified by New Mexico VA Healthcare System, August 2009
First Received: August 10, 2009 No Changes Posted
Sponsored by: VA Merit Review, DOD (Department of Defense)
Information provided by: New Mexico VA Healthcare System
ClinicalTrials.gov Identifier: NCT00956150
This study is currently recruiting participants.
Verified by New Mexico VA Healthcare System, August 2009
First Received: August 10, 2009 No Changes Posted
Sponsored by: VA Merit Review, DOD (Department of Defense)
Information provided by: New Mexico VA Healthcare System
ClinicalTrials.gov Identifier: NCT00956150
Purpose
The adverse impact of GWS on the health of veterans and on the resources of the VA Healthcare System underscores the need to resolve its underlying cause. In response, the investigators propose to investigate the central hypothesis that gut bacteria may be responsible for symptoms associated with GWS. The investigators will enroll a total of 160 patients with GWS and 90 healthy controls. The investigators will assess the prevalence and role of abnormal gut microbial fermentation among Veterans with GWS and investigate the efficacy of diagnostic and treatment strategies directed at indigenous gut microbes in the management of GWS.
The adverse impact of GWS on the health of veterans and on the resources of the VA Healthcare System underscores the need to resolve its underlying cause. In response, the investigators propose to investigate the central hypothesis that gut bacteria may be responsible for symptoms associated with GWS. The investigators will enroll a total of 160 patients with GWS and 90 healthy controls. The investigators will assess the prevalence and role of abnormal gut microbial fermentation among Veterans with GWS and investigate the efficacy of diagnostic and treatment strategies directed at indigenous gut microbes in the management of GWS.
Condition Intervention
Gulf War Syndrome
Procedure: Lactulose Breath Test
Drug: Rifaximin
Drug: Placebo
Drug: Erythromycin ethylsuccinate (EES)
Drug: Bismuth subsalicylate
Gulf War Syndrome
Procedure: Lactulose Breath Test
Drug: Rifaximin
Drug: Placebo
Drug: Erythromycin ethylsuccinate (EES)
Drug: Bismuth subsalicylate
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
Resource links provided by NLM:
Drug Information available for: Dioctyl sulfosuccinic acid Bismuth subsalicylate Erythromycin Gluceptate Rifaximin Erythromycin Docusate calcium Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate Lactulose Bismuth Kaopectate
U.S. FDA Resources
U.S. FDA Resources
Further study details as provided by New Mexico VA Healthcare System:
Primary Outcome Measures:
•To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test [ Time Frame: every 15 minutes for 180 minutes ] [ Designated as safety issue: No ]
•To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test [ Time Frame: every 15 minutes for 180 minutes ] [ Designated as safety issue: No ]
•To determine the response to antibiotic treatment in Gulf War Syndrome patients. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 210
Study Start Date: April 2009
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GWS and Controls: Active Comparator Procedure: Lactulose Breath Test
60 GWS Rifaximin: Active Comparator Drug: Rifaximin
Rifaximin 600 mg TID PO x 10 days
20 GWS Placebo: Placebo Comparator Drug: Placebo
Placebo at bedtime PO
40 GWS Bismuth: Active Comparator Drug: Bismuth subsalicylate
Bismuth subsalicylate 524 mg tablets QID x 7 days
60 GWS Placebo: Placebo Comparator Drug: Placebo
Placebo TID PO x 10 days
20 GWS Eythromycin: Active Comparator Drug: Erythromycin ethylsuccinate (EES)
Erythromycin 50 mg PO at bedtime
Study Start Date: April 2009
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GWS and Controls: Active Comparator Procedure: Lactulose Breath Test
60 GWS Rifaximin: Active Comparator Drug: Rifaximin
Rifaximin 600 mg TID PO x 10 days
20 GWS Placebo: Placebo Comparator Drug: Placebo
Placebo at bedtime PO
40 GWS Bismuth: Active Comparator Drug: Bismuth subsalicylate
Bismuth subsalicylate 524 mg tablets QID x 7 days
60 GWS Placebo: Placebo Comparator Drug: Placebo
Placebo TID PO x 10 days
20 GWS Eythromycin: Active Comparator Drug: Erythromycin ethylsuccinate (EES)
Erythromycin 50 mg PO at bedtime
Eligibility
Ages Eligible for Study: 21 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Inclusion Criteria:
•Gulf War Veterans meeting the 1994 CDC criteria for the diagnosis of CFS, i.e > six months of one or more symptoms from at least two of the following three clusters: general fatigue, mood and cognitive abnormalities, and musculoskeletal pain
•Must be under the care of a primary physician and have had a previous diagnosis of Gulf War-related illness or GWS and have medical records documenting investigations to rule out other causes of fatigue
•Minimum of the following laboratory screening tests: complete blood count with leukocyte differential, erythrocyte sedimentation rate, serum electrolytes, calcium, glucose, blood urea nitrogen, creatinine,urinalysis, and thyroid function tests
•Subjects must also have a GI consult first as part of routine care to confirm eligibility and availability
•Patients with IBS, FM, anxiety or depression will not be excluded, but will be identified for subgroup analysis
•Healthy controls will be screened with CBC and comprehensive metabolic panel to confirm eligibility
Exclusion Criteria:
•Must be under the care of a primary physician and have had a previous diagnosis of Gulf War-related illness or GWS and have medical records documenting investigations to rule out other causes of fatigue
•Minimum of the following laboratory screening tests: complete blood count with leukocyte differential, erythrocyte sedimentation rate, serum electrolytes, calcium, glucose, blood urea nitrogen, creatinine,urinalysis, and thyroid function tests
•Subjects must also have a GI consult first as part of routine care to confirm eligibility and availability
•Patients with IBS, FM, anxiety or depression will not be excluded, but will be identified for subgroup analysis
•Healthy controls will be screened with CBC and comprehensive metabolic panel to confirm eligibility
Exclusion Criteria:
•History of peptic ulcer, inflammatory bowel disease, diabetes, cirrhosis, rheumatoid arthritis, lupus, narcotic dependence,celiac disease, tropical sprue, bowel resection(including gastric, small bowel or colon; but gallbladder surgery or appendectomy are NOT exclusion criteria)
•Patients with chronic illness (HIV, tuberculosis)
•Pregnant or breast-feeding, psychotic depression, bipolar disorder, schizophrenia, eating disorders
•Healthy subjects will be excluded if their questionnaire indicated abnormal symptom profile
Contacts and Locations
•Patients with chronic illness (HIV, tuberculosis)
•Pregnant or breast-feeding, psychotic depression, bipolar disorder, schizophrenia, eating disorders
•Healthy subjects will be excluded if their questionnaire indicated abnormal symptom profile
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956150
Contacts
Contact: Lisa R Fowles, BS 505-265-1711 ext 2286 [email protected]
Contact: Henry C Lin, MD 505-265-1711 ext 4511 [email protected]
Contact: Lisa R Fowles, BS 505-265-1711 ext 2286 [email protected]
Contact: Henry C Lin, MD 505-265-1711 ext 4511 [email protected]
Locations
United States, New Mexico
New Mexico VA Healthcare System Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Lisa R Fowles, BS 505-265-1711 ext 2286 [email protected]
Contact: Henry C Lin, MD 505-265-1711 ext 4511 [email protected]
Principal Investigator: Henry C Lin, MD
Sponsors and Collaborators
VA Merit Review, DOD (Department of Defense)
More Information
United States, New Mexico
New Mexico VA Healthcare System Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Lisa R Fowles, BS 505-265-1711 ext 2286 [email protected]
Contact: Henry C Lin, MD 505-265-1711 ext 4511 [email protected]
Principal Investigator: Henry C Lin, MD
Sponsors and Collaborators
VA Merit Review, DOD (Department of Defense)
More Information
No publications provided
Responsible Party: VA Healthcare System ( Henry C. Lin, MD )
Study ID Numbers: HRRC 07-155
Study First Received: August 10, 2009
Last Updated: August 10, 2009
ClinicalTrials.gov Identifier: NCT00956150 History of Changes
Health Authority: United States: Food and Drug Administration
Study ID Numbers: HRRC 07-155
Study First Received: August 10, 2009
Last Updated: August 10, 2009
ClinicalTrials.gov Identifier: NCT00956150 History of Changes
Health Authority: United States: Food and Drug Administration
Keywords provided by New Mexico VA Healthcare System:
Chronic Multisymptom Complex
Small Intestinal Bacterial Overgrowth
Gulf War Syndrome
Chronic Multisymptom Illness Complex
Chronic Multisymptom Complex
Small Intestinal Bacterial Overgrowth
Gulf War Syndrome
Chronic Multisymptom Illness Complex
Additional relevant MeSH terms:
Persian Gulf Syndrome
Erythromycin stearate
Anti-Infective Agents
Disease
Molecular Mechanisms of Pharmacological Action
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Disorders of Environmental Origin
Enzyme Inhibitors
Erythromycin
Pharmacologic Actions
Bismuth subsalicylate
Antidiarrheals
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Pathologic Processes
Erythromycin Estolate
Therapeutic Uses
Syndrome
Occupational
Persian Gulf Syndrome
Erythromycin stearate
Anti-Infective Agents
Disease
Molecular Mechanisms of Pharmacological Action
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Disorders of Environmental Origin
Enzyme Inhibitors
Erythromycin
Pharmacologic Actions
Bismuth subsalicylate
Antidiarrheals
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Pathologic Processes
Erythromycin Estolate
Therapeutic Uses
Syndrome
Occupational
———————————————————————————————————–
3. A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
This study is currently recruiting participants.
Verified by Bronx Veterans Medical Research Foundation, Inc, June 2008
First Received: June 3, 2008 Last Updated: June 4, 2008 History of Changes
Sponsors and Collaborators: Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Information provided by: Bronx Veterans Medical Research Foundation, Inc
ClinicalTrials.gov Identifier: NCT00691067
This study is currently recruiting participants.
Verified by Bronx Veterans Medical Research Foundation, Inc, June 2008
First Received: June 3, 2008 Last Updated: June 4, 2008 History of Changes
Sponsors and Collaborators: Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Information provided by: Bronx Veterans Medical Research Foundation, Inc
ClinicalTrials.gov Identifier: NCT00691067
Purpose
We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine its effects on physical and mental health and cognitive functioning. In addition, we propose to examine whether HPA axis biomarkers or their response to mifepristone are useful predictors of clinical response.
We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine its effects on physical and mental health and cognitive functioning. In addition, we propose to examine whether HPA axis biomarkers or their response to mifepristone are useful predictors of clinical response.
Condition Intervention Phase
Chronic Multisymptom Illness in Gulf War Veterans
Drug: mifepristone
Drug: placebo
Phase IV
Chronic Multisymptom Illness in Gulf War Veterans
Drug: mifepristone
Drug: placebo
Phase IV
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title: A Randomized, Double-Blind Placebo-Controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title: A Randomized, Double-Blind Placebo-Controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
Resource links provided by NLM:
Drug Information available for: Mifepristone
U.S. FDA Resources
U.S. FDA Resources
Further study details as provided by Bronx Veterans Medical Research Foundation, Inc:
Primary Outcome Measures:
•change in the health components score of the veterans RAND 36-item health survey (VR-36) [ Time Frame: baseline, every two weeks, endpoint ] [ Designated as safety issue: No ]
•change in the health components score of the veterans RAND 36-item health survey (VR-36) [ Time Frame: baseline, every two weeks, endpoint ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
•cognitive functioning and measures of depression, fatigue and PTSD [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]
•cognitive functioning and measures of depression, fatigue and PTSD [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]
Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
Drug: mifepristone
200 mg po per day x 6 weeks
Drug: placebo
placebo
Eligibility
Drug: mifepristone
200 mg po per day x 6 weeks
Drug: placebo
placebo
Eligibility
Ages Eligible for Study: 35 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Inclusion Criteria:
•Veteran of the 1991 Gulf War
•Veteran meets criteria for multisymptom illness
Exclusion Criteria:
•Veteran meets criteria for multisymptom illness
Exclusion Criteria:
•Veteran lacks the capacity to provide consent.
•Veteran has a major medical or neurological disorder or traumatic brain injury
•Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency
•Veteran has a fasting blood glucose ≥ 110 mcg/dl
•Veteran is taking oral corticosteroids
•Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
•Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years
•Veteran has current suicidal ideation
•Veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not willing to use appropriate forms of contraception during the study and for at least 90 days post treatment.
•Women veterans with diseases of the uterus by history or a family history of uterine cancer
•Known allergy to mifepristone
Contacts and Locations
•Veteran has a major medical or neurological disorder or traumatic brain injury
•Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency
•Veteran has a fasting blood glucose ≥ 110 mcg/dl
•Veteran is taking oral corticosteroids
•Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
•Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years
•Veteran has current suicidal ideation
•Veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not willing to use appropriate forms of contraception during the study and for at least 90 days post treatment.
•Women veterans with diseases of the uterus by history or a family history of uterine cancer
•Known allergy to mifepristone
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691067
Contacts
Contact: Julia A Golier, M.D. 718-584-9000 ext 5196 [email protected]
Contact: Julia A Golier, M.D. 718-584-9000 ext 5196 [email protected]
Locations
United States, New York
James J Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Julia A Golier, M.D. 718-584-9000 ext 5196 [email protected]
Principal Investigator: Julia A Golier, M.D.
Sponsors and Collaborators
Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Julia A Golier, M.D. James J Peters VA Medical Center
United States, New York
James J Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Julia A Golier, M.D. 718-584-9000 ext 5196 [email protected]
Principal Investigator: Julia A Golier, M.D.
Sponsors and Collaborators
Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Julia A Golier, M.D. James J Peters VA Medical Center
More Information
No publications provided
Responsible Party: James J Peters VA Medical Center ( Julia Golier, M.D. )
Study ID Numbers: GW060048
Study First Received: June 3, 2008
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00691067 History of Changes
Health Authority: United States: Food and Drug Administration
Study ID Numbers: GW060048
Study First Received: June 3, 2008
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00691067 History of Changes
Health Authority: United States: Food and Drug Administration
Additional relevant MeSH terms:
Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Mifepristone
Reproductive Control Agents
Luteolytic Agents
Contraceptives, Postcoital
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic
—————————————————————————————–
Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Mifepristone
Reproductive Control Agents
Luteolytic Agents
Contraceptives, Postcoital
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic
—————————————————————————————–
4. Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome
This study is currently recruiting participants.
Verified by Georgetown University, November 2008
First Received: December 17, 2008 No Changes Posted
Sponsors and Collaborators: Georgetown University
National Institute of Environmental Health Sciences (NIEHS)
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00810329
This study is currently recruiting participants.
Verified by Georgetown University, November 2008
First Received: December 17, 2008 No Changes Posted
Sponsors and Collaborators: Georgetown University
National Institute of Environmental Health Sciences (NIEHS)
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00810329
Purpose
The purpose of this study is:
The purpose of this study is:
1.To look for specific set of proteins in the cerebrospinal fluid ( fluid surrounding the brain and the spinal cord), that are believed to be seen in Chronic fatigue syndrome patients, but not in healthy controls. A similar study that the investigators had conducted before,suggests that significant changes in proteins in the cerebrospinal fluid may be due to the fundamental pathology of this disorder.
2.Increased cerebrospinal fluid pressure (pressure that helps the cerebrospinal fluid to move around the brain and the spinal cord), may be related with certain symptoms like headache, sleep problems, light headedness, increased pain, excessive tiredness (fatigue) even with minimal work and memory problems.
2.Increased cerebrospinal fluid pressure (pressure that helps the cerebrospinal fluid to move around the brain and the spinal cord), may be related with certain symptoms like headache, sleep problems, light headedness, increased pain, excessive tiredness (fatigue) even with minimal work and memory problems.
Condition
Chronic Fatigue Syndrome
Fibromyalgia
Gulf War Illness
Multiple Chemical Sensitivity
Interstitial Cystitis
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Fibromyalgia
Gulf War Illness
Multiple Chemical Sensitivity
Interstitial Cystitis
Irritable Bowel Syndrome
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Study Looking for Unique Set of Proteins in Cerebrospinal Fluid, Which Are Believed to be Found in Chronic Fatigue Syndrome Participants, But Not in Healthy Controls.
Study Design: Cohort, Prospective
Official Title: Study Looking for Unique Set of Proteins in Cerebrospinal Fluid, Which Are Believed to be Found in Chronic Fatigue Syndrome Participants, But Not in Healthy Controls.
Resource links provided by NLM:
MedlinePlus related topics: Chronic Fatigue Syndrome Fibromyalgia Interstitial Cystitis
U.S. FDA Resources
U.S. FDA Resources
Further study details as provided by Georgetown University:
Primary Outcome Measures:
•Differences in the proteins in the fluid around the brain, between Chronic fatigue syndrome and Healthy subjects. These proteins may identify the disease and define its mechanism. [ Time Frame: 3 – 4 years ] [ Designated as safety issue: No ]
•Differences in the proteins in the fluid around the brain, between Chronic fatigue syndrome and Healthy subjects. These proteins may identify the disease and define its mechanism. [ Time Frame: 3 – 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
•Blood pressure differences in response to exercise, blood tests, questionnaire results and sensory nerve testing to determine the role(s) of altered nerve and brain function in Chronic fatigue syndrome. [ Time Frame: 3- 4 years ] [ Designated as safety issue: No ]
•Blood pressure differences in response to exercise, blood tests, questionnaire results and sensory nerve testing to determine the role(s) of altered nerve and brain function in Chronic fatigue syndrome. [ Time Frame: 3- 4 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Biospecimen Description:
Cheek swabs, on the right inner cheek and on the left inner cheek. Others:Blood samples and Urine samples.
Cheek swabs, on the right inner cheek and on the left inner cheek. Others:Blood samples and Urine samples.
Estimated Enrollment: 150
Study Start Date: January 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
This group consists of patients with Chronic fatigue syndrome, Fibromyalgia and other conditions like Multiple chemical sensitivity, Irritable bowel syndrome, Interstitial Cystitis, Gulf War Illness.
2
The healthy control group
Study Start Date: January 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
This group consists of patients with Chronic fatigue syndrome, Fibromyalgia and other conditions like Multiple chemical sensitivity, Irritable bowel syndrome, Interstitial Cystitis, Gulf War Illness.
2
The healthy control group
Detailed Description:
Neurological dysfunction is a key component of the clinical expression and case designation of chronic fatigue syndrome (CFS), fibromyalgia (FM)and other related conditions.If the central nervous system is involved, then evidence will be present in the cerebrospinal fluid. Distinct patterns of proteins will be present in Chronic fatigue syndrome (CFS) compared to healthy control (HC) subjects.
Neurological dysfunction is a key component of the clinical expression and case designation of chronic fatigue syndrome (CFS), fibromyalgia (FM)and other related conditions.If the central nervous system is involved, then evidence will be present in the cerebrospinal fluid. Distinct patterns of proteins will be present in Chronic fatigue syndrome (CFS) compared to healthy control (HC) subjects.
Other testing in our study would include,1. Assessment of lung capacity and scoring the shortness of breath as a result of breathing testing also called as the Pulmonary function testing (PFT).
2. Compare the blood pressure and heart rate response before and after hand grip exercise testing.
3. Skin tests like the i) Capsaicin skin test, to check for specific responses like burning sensation, area of skin redness, itchy sensation to varying doses of capsaicin (essence of chilli pepper), when placed on the forearm and to compare if there are any differences seen between the responses in CFS and Healthy controls. ii) Allergy skin test to look if there are any allergies that are seen in the set of CFS population.
4. 18 tenderness point testing to compare the pain threshold before and after the lumbar puncture also know as the spinal tap. 18 tenderness point testing is a diagnostic test for Fibromyalgia.
5. Many of the participants with CFS do have associated Migraine headaches and they complain of severe light sensitivity and loud noises could give them headache. We are analysing those group of people and decision have to be made as to which medications would work at best and give them immediate relief from headache in these group of participants.
Eligibility
Ages Eligible for Study: 21 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample
Study Population
1.Georgetown University Division of Rheumatology, Immunology and Allergy and other Divisions
2.IRB-approved websites and support groups.
3.IRB- approved advertisments
4.Self-referral.
Criteria
Inclusion Criteria:
1.Georgetown University Division of Rheumatology, Immunology and Allergy and other Divisions
2.IRB-approved websites and support groups.
3.IRB- approved advertisments
4.Self-referral.
Criteria
Inclusion Criteria:
1.Chronic Fatigue Syndrome
2.Fibromyalgia
3.Gulf War Illness
4.Multiple Chemical Sensitivity
5.Irritable Bowel Syndrome
6.Interstitial Cystitis
Exclusion Criteria:
2.Fibromyalgia
3.Gulf War Illness
4.Multiple Chemical Sensitivity
5.Irritable Bowel Syndrome
6.Interstitial Cystitis
Exclusion Criteria:
1.You do not want to have a lumbar puncture performed.
2.You have a severe physical impairment that does not permit lumbar puncture or completion of the remainder of the tests (e.g. severe scoliosis or curvature of the back).
3.You have a medical condition with symptoms similar to Chronic Fatigue Syndrome such as regional pain syndromes, reflex sympathetic dystrophy, morbid obesity, autoimmune / inflammatory diseases, cardiopulmonary disorders), neurological disorders (e.g. seizures, dementia, degenerative disorders), uncontrolled endocrine or allergic diseases or, cancer.
4.You have a severe psychiatric illness such as schizophrenia, substance abuse, major depression with previous suicidal attempts, gestures or ideas about committing suicide.
5.You are mentally retarded or cannot understand this informed consent, cannot provide absolute willingness to have a lumbar puncture as part of this study, or are unable to complete the questionnaires and other studies that are part of this research project
6.You are in jail or prison.
7.You are pregnant.
8.You smoke more than 5 cigarettes per day. You will be allowed to taper your smoking before your participation in the actual study visit. This is an excellent opportunity to ask about our Smoking Cessation Programs.
9.You drink or eat caffeine containing products with more than the equivalent of 2 cups of coffee. You will be allowed to taper your caffeine intake before the study visit.
10.You have used narcotics or other illegal medications for more than 3 months. These will be discussed with Dr. Baraniuk.
11.You have a positive HIV test, or blood, liver or kidney tests that are abnormal.
12.You are participating only so you can be paid for taking part in this spinal tap study.
Contacts and Locations
2.You have a severe physical impairment that does not permit lumbar puncture or completion of the remainder of the tests (e.g. severe scoliosis or curvature of the back).
3.You have a medical condition with symptoms similar to Chronic Fatigue Syndrome such as regional pain syndromes, reflex sympathetic dystrophy, morbid obesity, autoimmune / inflammatory diseases, cardiopulmonary disorders), neurological disorders (e.g. seizures, dementia, degenerative disorders), uncontrolled endocrine or allergic diseases or, cancer.
4.You have a severe psychiatric illness such as schizophrenia, substance abuse, major depression with previous suicidal attempts, gestures or ideas about committing suicide.
5.You are mentally retarded or cannot understand this informed consent, cannot provide absolute willingness to have a lumbar puncture as part of this study, or are unable to complete the questionnaires and other studies that are part of this research project
6.You are in jail or prison.
7.You are pregnant.
8.You smoke more than 5 cigarettes per day. You will be allowed to taper your smoking before your participation in the actual study visit. This is an excellent opportunity to ask about our Smoking Cessation Programs.
9.You drink or eat caffeine containing products with more than the equivalent of 2 cups of coffee. You will be allowed to taper your caffeine intake before the study visit.
10.You have used narcotics or other illegal medications for more than 3 months. These will be discussed with Dr. Baraniuk.
11.You have a positive HIV test, or blood, liver or kidney tests that are abnormal.
12.You are participating only so you can be paid for taking part in this spinal tap study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810329
Contacts
Contact: Murugan K Ravindran, MD 202-687-8231 [email protected], [email protected], [email protected]
Contact: Murugan K Ravindran, MD 202-687-8231 [email protected], [email protected], [email protected]
Locations
United States, District of Columbia
Georgetown University Hospital, 3800 Reservoir Rd NW Recruiting
Washington, District of Columbia, United States, 20007
Contact: Murugan K Ravindran, MD 202-687-8231 [email protected]
Principal Investigator: James N Baraniuk, MD
Sub-Investigator: Hilda Maibach
Sub-Investigator: Vance Watson, MD
Sub-Investigator: . Fraser C Henderson, MD
Sub-Investigator: Cristina Di Poto, Ph.D
Sub-Investigator: Habtom Ressom, Ph.D
Sub-Investigator: Lewis Pannell, Ph.D
Sub-Investigator: Peter Burbelo, Ph.D
Sponsors and Collaborators
Georgetown University
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University Hospital
United States, District of Columbia
Georgetown University Hospital, 3800 Reservoir Rd NW Recruiting
Washington, District of Columbia, United States, 20007
Contact: Murugan K Ravindran, MD 202-687-8231 [email protected]
Principal Investigator: James N Baraniuk, MD
Sub-Investigator: Hilda Maibach
Sub-Investigator: Vance Watson, MD
Sub-Investigator: . Fraser C Henderson, MD
Sub-Investigator: Cristina Di Poto, Ph.D
Sub-Investigator: Habtom Ressom, Ph.D
Sub-Investigator: Lewis Pannell, Ph.D
Sub-Investigator: Peter Burbelo, Ph.D
Sponsors and Collaborators
Georgetown University
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University Hospital
More Information
Publications:
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome – related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome – related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.
Responsible Party: Georgetown University Hospital ( James N Baraniuk MD, Associate Professor of Medicine )
Study ID Numbers: 2006-481, RO1 ES015382
Study First Received: December 17, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00810329 History of Changes
Health Authority: United States: Federal Government
Study ID Numbers: 2006-481, RO1 ES015382
Study First Received: December 17, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00810329 History of Changes
Health Authority: United States: Federal Government
Keywords provided by Georgetown University:
CFS,FM,CSF,Proteomics,Pain,Fatigue,GWI,IBS,IC,MCS.
CFS,FM,CSF,Proteomics,Pain,Fatigue,GWI,IBS,IC,MCS.
Additional relevant MeSH terms:
Environmental Illness
Gastrointestinal Diseases
Colonic Diseases
Disorders of Environmental Origin
Encephalomyelitis
Fatigue Syndrome, Chronic
Signs and Symptoms
Hypersensitivity
Pathologic Processes
Urologic Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Syndrome
Irritable Bowel Syndrome
Multiple Chemical Sensitivity
Disease
Fatigue
Immune System Diseases
Myofascial Pain Syndromes
Fibromyalgia
Urinary Bladder Diseases
Nervous System Diseases
Cystitis
Central Nervous System Diseases
Rheumatic Diseases
Intestinal Diseases
Virus Diseases
Cystitis, Interstitial
Muscular Diseases
Digestive System Diseases
Environmental Illness
Gastrointestinal Diseases
Colonic Diseases
Disorders of Environmental Origin
Encephalomyelitis
Fatigue Syndrome, Chronic
Signs and Symptoms
Hypersensitivity
Pathologic Processes
Urologic Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Syndrome
Irritable Bowel Syndrome
Multiple Chemical Sensitivity
Disease
Fatigue
Immune System Diseases
Myofascial Pain Syndromes
Fibromyalgia
Urinary Bladder Diseases
Nervous System Diseases
Cystitis
Central Nervous System Diseases
Rheumatic Diseases
Intestinal Diseases
Virus Diseases
Cystitis, Interstitial
Muscular Diseases
Digestive System Diseases
_________________________________________________________
5. Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
This study is currently recruiting participants.
Verified by Georgetown University, July 2009
First Received: December 17, 2008 Last Updated: July 2, 2009 History of Changes
Sponsored by: Georgetown University
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00810368
This study is currently recruiting participants.
Verified by Georgetown University, July 2009
First Received: December 17, 2008 Last Updated: July 2, 2009 History of Changes
Sponsored by: Georgetown University
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00810368
Purpose
The purpose of this study is to perform a randomized double-blind, placebo-controlled, six month study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle strength outcomes in 100 GWI subjects.
The purpose of this study is to perform a randomized double-blind, placebo-controlled, six month study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle strength outcomes in 100 GWI subjects.
Condition Intervention Phase
Gulf War Illness
Drug: Carnosine
Drug: Placebo
Phase II
Gulf War Illness
Drug: Carnosine
Drug: Placebo
Phase II
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Carnosine in Gulf War Illness (GWI)
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Carnosine in Gulf War Illness (GWI)
Resource links provided by NLM:
Drug Information available for: Carnosine
U.S. FDA Resources
U.S. FDA Resources
Further study details as provided by Georgetown University:
Primary Outcome Measures:
•Determine if 6 months of oral carnosine 500 mg twice daily has significant, beneficial effects on:(1)activity, 2)cognitive, 3)plasma proteomic outcomes compared to placebo. [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
•Determine if 6 months of oral carnosine 500 mg twice daily has significant, beneficial effects on:(1)activity, 2)cognitive, 3)plasma proteomic outcomes compared to placebo. [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
•Determine the safety of carnosine 500 mg twice daily in GWI volunteers. [ Time Frame: 09/2011 ] [ Designated as safety issue: Yes ]
•Determine the safety of carnosine 500 mg twice daily in GWI volunteers. [ Time Frame: 09/2011 ] [ Designated as safety issue: Yes ]
•Determine if responses to carnosine can be stratified according to "long" versus "short" alleles of the CNDP1 gene. CNDP1 degrades carnosine. [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
•Assess longitudinal changes in the placebo group (natural history of symptom variation in GWI). [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
Estimated Enrollment: 258
Study Start Date: August 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Carnosine treatment group Drug: Carnosine
500mg Carnosine x2 daily
2: Placebo Comparator
Placebo control group Drug: Placebo
Microcrystalline cellulose placebo tablets x2 daily
Study Start Date: August 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Carnosine treatment group Drug: Carnosine
500mg Carnosine x2 daily
2: Placebo Comparator
Placebo control group Drug: Placebo
Microcrystalline cellulose placebo tablets x2 daily
Eligibility
Ages Eligible for Study: 34 Years to 82 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Inclusion Criteria:
•Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:
◦Persian Gulf waters and adjacent land areas,
◦Other global locations, or,
◦U.S. only. 1990-1991 enlistment status:
◦Active duty
◦National Guard
◦Reserves
Exclusion Criteria:
◦Other global locations, or,
◦U.S. only. 1990-1991 enlistment status:
◦Active duty
◦National Guard
◦Reserves
Exclusion Criteria:
•HIV/AIDS
•Pregnant Women
•Active Duty Military Personnel
•Children
•Incarceration
Contacts and Locations
•Pregnant Women
•Active Duty Military Personnel
•Children
•Incarceration
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810368
Contacts
Contact: Yin Zheng 202-687-8231 [email protected]
Contact: Murugan K Ravindran, MD 202-687-8231 [email protected]
Contact: Yin Zheng 202-687-8231 [email protected]
Contact: Murugan K Ravindran, MD 202-687-8231 [email protected]
Locations
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Samantha J Merck 202-687-8231 [email protected]
Principal Investigator: James N Baraniuk, MD
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Samantha J Merck 202-687-8231 [email protected]
Principal Investigator: James N Baraniuk, MD
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University
More Information
Publications:
Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302.
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome – related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.
Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Köppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7.
Chez MG, Buchanan CP, Aimonovitch MC, Becker M, Schaefer K, Black C, Komen J. Double-blind, placebo-controlled study of L-carnosine supplementation in children with autistic spectrum disorders. J Child Neurol. 2002 Nov;17(11):833-7.
Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302.
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome – related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.
Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Köppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7.
Chez MG, Buchanan CP, Aimonovitch MC, Becker M, Schaefer K, Black C, Komen J. Double-blind, placebo-controlled study of L-carnosine supplementation in children with autistic spectrum disorders. J Child Neurol. 2002 Nov;17(11):833-7.
Responsible Party: Georgetown University ( James N. Baraniuk, MD )
Study ID Numbers: IRB-2008-068, USAMRMC PR# W91ZSQ-7149-N602, HRPO Log No. A-14542.2
Study First Received: December 17, 2008
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00810368 History of Changes
Health Authority: United States: Food and Drug Administration; United States: Federal Government
Study ID Numbers: IRB-2008-068, USAMRMC PR# W91ZSQ-7149-N602, HRPO Log No. A-14542.2
Study First Received: December 17, 2008
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00810368 History of Changes
Health Authority: United States: Food and Drug Administration; United States: Federal Government
Keywords provided by Georgetown University:
Carnosine
GWI
Gulf War Illness
Carnosine
GWI
Gulf War Illness
————————————————————————————————————-
6. Study of Gulf War Illness (GWI) by Comparing GWI and Healthy Veterans
This study is currently recruiting participants.
Verified by Georgetown University, July 2009
First Received: December 17, 2008 Last Updated: July 2, 2009 History of Changes
Sponsors and Collaborators: Georgetown University
U.S. Army Medical Research and Materiel Command
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00810225
This study is currently recruiting participants.
Verified by Georgetown University, July 2009
First Received: December 17, 2008 Last Updated: July 2, 2009 History of Changes
Sponsors and Collaborators: Georgetown University
U.S. Army Medical Research and Materiel Command
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00810225
Purpose
Determine if:
Determine if:
•genetic differences of CNDP1 gene
•the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid proteome contents
•psychometric
•other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms and those without these complaints.
•the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid proteome contents
•psychometric
•other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms and those without these complaints.
Condition
Gulf War Illness
Persian Gulf War Syndrome
Gulf War Illness
Persian Gulf War Syndrome
Study Type: Observational
Study Design: Case Control, Cross-Sectional
Official Title: CNDP1 Polymorphisms in Gulf War Illness (GWI)
Study Design: Case Control, Cross-Sectional
Official Title: CNDP1 Polymorphisms in Gulf War Illness (GWI)
Further study details as provided by Georgetown University:
Biospecimen Retention: Samples With DNA
Biospecimen Description:
Plasma, serum, urine, and buccal swab samples retained for testing as described in protocol.
Plasma, serum, urine, and buccal swab samples retained for testing as described in protocol.
Estimated Enrollment: 516
Study Start Date: August 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
GWI: veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
2
HC: healthy veterans of the 1990-1991 Persian Gulf War
Study Start Date: August 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
GWI: veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
2
HC: healthy veterans of the 1990-1991 Persian Gulf War
Eligibility
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Study Population
All veterans who served in the Armed Forces between August 1990 and July 1991
All veterans who served in the Armed Forces between August 1990 and July 1991
Criteria
Inclusion Criteria:
Inclusion Criteria:
•Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:
◦Persian Gulf waters and adjacent land areas
◦Other global locations
◦U.S. only
•Status prior to 1990 and 1991:
◦Other global locations
◦U.S. only
•Status prior to 1990 and 1991:
◦Active duty
◦National Guard
◦Reserves
Exclusion Criteria:
◦National Guard
◦Reserves
Exclusion Criteria:
•Current active duty military personnel
•Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991
•HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests.
Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested
•Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991
•HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests.
Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810225
Contacts
Contact: Yin Zheng 202-687-8231 [email protected]
Contact: Murugan K Ravindran, MD 202-687-8231 [email protected]
Contact: Yin Zheng 202-687-8231 [email protected]
Contact: Murugan K Ravindran, MD 202-687-8231 [email protected]
Locations
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Samantha J Merck 202-687-8231 [email protected]
Principal Investigator: James N Baraniuk, MD
Sponsors and Collaborators
Georgetown University
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Samantha J Merck 202-687-8231 [email protected]
Principal Investigator: James N Baraniuk, MD
Sponsors and Collaborators
Georgetown University
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University
More Information
Publications:
Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302.
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome – related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.
Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Köppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7.
Casado B, Zanone C, Annovazzi L, Iadarola P, Whalen G, Baraniuk JN. Urinary electrophoretic profiles from chronic fatigue syndrome and chronic fatigue syndrome/fibromyalgia patients: a pilot study for achieving their normalization. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Jan 5;814(1):43-51.
Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8.
Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302.
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome – related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.
Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Köppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7.
Casado B, Zanone C, Annovazzi L, Iadarola P, Whalen G, Baraniuk JN. Urinary electrophoretic profiles from chronic fatigue syndrome and chronic fatigue syndrome/fibromyalgia patients: a pilot study for achieving their normalization. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Jan 5;814(1):43-51.
Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8.
Responsible Party: Georgetown University ( James N. Baraniuk, MD )
Study ID Numbers: 2008-012, USAMRMC PR# W81XWH-07-1-0618, HRPO Log No. A-14542.1
Study First Received: December 17, 2008
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00810225 History of Changes
Health Authority: United States: Institutional Review Board; United States: Federal Government
Study ID Numbers: 2008-012, USAMRMC PR# W81XWH-07-1-0618, HRPO Log No. A-14542.1
Study First Received: December 17, 2008
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00810225 History of Changes
Health Authority: United States: Institutional Review Board; United States: Federal Government
Keywords provided by Georgetown University:
CNDP1
carnosine dipeptidase 1
GWI
Gulf War Illness
CNDP1
carnosine dipeptidase 1
GWI
Gulf War Illness
Additional relevant MeSH terms:
Pathologic Processes
Disease
Persian Gulf Syndrome
Syndrome
Disorders of Environmental Origin
Occupational Diseases
Pathologic Processes
Disease
Persian Gulf Syndrome
Syndrome
Disorders of Environmental Origin
Occupational Diseases
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