Desert Storm Veterans Get in Line and Volunteer for VA Funded Studies on Gulf War Illness

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Gulf War Illness: Call for Veterans to Participate on VA funded Gulf War Illness Studies

By Denise Nichols STAFF WRITER/Editor

There is a critical need to circulate information on VA and DOD Funded research for Desert Storm Veterans that are ill with Gulf War Illness especially during this time between January and March of this year since it is the 20th Anniversary of the Gulf War 1990-91.  Veterans if we are going to get answers and help for those ill with Gulf War Illness it is important that we focus on the good that is finally happening after a 20 year battle to get real research on a real illness.  A lot of work, sweat, and frustration has happened along this path to get the recognition and help for the veterans of Operation Desert Storm who came home ill and we are getting closer.  We need the focus and attention now and front page coverage.

WE need all veterans and civilians aware that there are probably more than the one in four ill(250,000) affected.  We also have current troops returning ill with similar symptoms.  We also have some of the nondeployed gulf war 1990-91 ill either from vaccines or secondary exposure from our equipment.

This writer is going to concentrate on getting volunteers ie Desert Storm Veterans to help each other by getting into various research projects.  Today’s focus will be on that ongoing battle in our gut!  You know what I mean the irritable bowels, the diarrhea and the constipation.  It does not take alot to know if you have neurological, immune, circulation problems that the gut is going to be affected but is there more there to be found.  The answer is yes ie biomarkers, diagnostic tests, and means to treat this situation.

The focus is find something to treat this.  If your bowels are not working your absorption of food and the energy dynamics to keep a body working are going to be affected.  Bowels also can be a source of huge amounts of waste products and if not dealt with then you are going to have more problems.  Leaky gut problems will complicate being able to recover!  Therefore the need to explore what is continuing this problem and how to treat it.  They need patients and controls(a control might just be your spouse, your brother, your cousin, other veterans in the same age group).

This study is being performed in New Mexico, so the veterans up north that are freezing might want to come south!  There are no travel funds available to help on that end.  But we need the veterans of the gulf war to try and help themselves and their fellow veterans by trying their best to get into the research to find answers and help!  Your Spouse, your brother, family members that are not sick but may match you or another veteran by age are needed to be recruited as control subjects!  So maybe you could travel together.

Please also write, email, fax  your congressman and ask that travel funds for veterans to participate in research be it for VA or DOD CDMRP be included or to allow veterans use of Space A or aeromedical evacuation flights to get to research programs or to allow for airlines to be used and bill it to DOD Travel.  Or find some way to assist veterans with these travel cost.

Also legislation should be set up to include that VA Research projects include a way that other VA hospitals can collect specimens for the researchers at a specific VA and to also have Nurse Coordinators at other VA hospitals that can get the informed consent signed and perform any questionnaire required in thee studies.  We just must have a way for veterans to more readily access these research studies and for it not to be a financial drain on the veterans that the research was set up to benefit!!

They are looking for 80 veterans as outlined below.  Then the need is for 40 control participants.  The study will involve 2 trips to this VA hospital in New Mexico.  Each trip will be about 4 hours at the hospital to collect informed consent, questionnaires, and samples needed for the study.  Then the treatment as outlined below and after that you go back to the hospital to give samples again, again for roughly 4 hours at the hospital.  It will be roughly 2 weeks apart for the visits.  The contact person to get into the study is Lisa Fowler at 505-265-1711 et. 2286.

The study has just gotten everything in order on their end to start taking in participants.  WE need 80 veterans of Desert Storm that meet the criteria below to take the steps!  The sooner we get the veterans and the controls, the sooner the research will get done, the sooner data can be collected and reports and study publication can be done in order to get answers and treatment going widespread.  The sooner we find out if this works or not also means the sooner other medical researchers will know about it and have other ideas that may help us all!

I am asking all to further distribute this article and the information!  I am asking that all veterans help to get the information out in all ways possible, make it go as we say viral.  WE also need civilians involved spreading this information far and wide!

WE have been delayed too long and are suffering.  This is one way all can help our fellow Desert Storm Veterans that are ill and suffering!  Now everyone get busy!  This also means getting the information to all Congress members and Senators and their staffers from DC to home offices so they can post information for Gulf War Veterans on their websites and distribute the information to their constituents of veterans, family members, civilians, and involved groups they communicate with on an ongoing basis.  It means to get this information out to your local media contacts all across the US and get it on TV locally, newspapers, radio talk shows, and etc.

If you are a veteran that wants to participate but are being stopped re funds to travel.  Then contact your service organizations and posts after you are accepted to participate and have a plan and how much you need for travel and ask for local posts to help you.  Organize a dinner ie spaghetti for a fund raiser.  Car Washes?  Whatever it takes!  And remember to write your comments to this article!  Additionally you can holler at [email protected] and let me know if you are doing it and if you need further ideas or help.

Below are the details:

Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
This study is currently recruiting participants.
Verified by New Mexico VA Healthcare System, February 2010
First Received: August 10, 2009   Last Updated: February 25, 2010
Sponsor: VA Merit Review, DOD (Department of Defense)
Information provided by: New Mexico VA Healthcare System
ClinicalTrials 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.

Condition Intervention
Gulf War Syndrome Procedure: Lactulose Breath Test
Drug: Rifaximin
Drug: Placebo
Drug: Erythromycin ethylsuccinate (EES)
Drug: Bismuth subsalicylate
Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

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 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

Intervention: Procedure: Lactulose Breath Test
Procedure: Lactulose Breath Test
60 GWS Rifaximin: Active Comparator

Intervention: Drug: Rifaximin
Drug: Rifaximin

Rifaximin 600 mg TID PO x 10 days
20 GWS Placebo: Placebo Comparator

Intervention: Drug: Placebo
Drug: Placebo

Placebo at bedtime PO
40 GWS Bismuth: Active Comparator

Intervention: Drug: Bismuth subsalicylate
Drug: Bismuth subsalicylate

Bismuth subsalicylate 524 mg tablets QID x 7 days
60 GWS Placebo: Placebo Comparator

Intervention: Drug: Placebo
Drug: Placebo

Placebo TID PO x 10 days
20 GWS Eythromycin: Active Comparator

Intervention: Drug: Erythromycin ethylsuccinate (EES)
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
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:

  • 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
Contacts
Contact: Lisa R Fowles, BS 505-265-1711 ext 2286 [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]
Principal Investigator: Henry C Lin, MD

Sponsors and Collaborators
VA Merit Review, DOD (Department of Defense)

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