Gulf War Digestive Health Study (NCT00680836) | Clinical Trial Compass
CompletedNot Applicable
Gulf War Digestive Health Study
United States54 participantsStarted 2007-10
Plain-language summary
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth (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.
Who can participate
Age range
35 Years – 72 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Global Improvement Scale
Timeframe: Measured for seven days at the end of 2 weeks treatment and average score is calculated