Irritable Bowel Syndrome Clinical Trial
Official title:
Mechanisms of Gulf War Illness
Many veterans with Gulf War Illness developed chronic gastrointestinal symptoms during their deployment to the Persian Gulf. The pathophysiologic mechanisms of these chronic gastrointestinal symptoms are not well understood but cause significant morbidity in veterans. Our proposed studies will provide an innovative and novel treatment trial for chronic gastrointestinal symptoms in veterans with Gulf War Illness that were deployed into war zones. Given that there are currently no specific treatments for these disorders, and that current symptomatic approaches are far from ideal, proof of principle of our trial would be an extremely important advance as it would not only have a beneficial impact on the health of many thousands of our veterans, but also it would substantially reduce the many negative economic effects of this ailment on the VA Health Care System.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 31, 2027 |
Est. primary completion date | July 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating) that started during their deployment in the Persian Gulf 2. increased intestinal permeability on the lactulose/mannitol permeability test (ratio >0.07) 3. able and willing to cooperate with the study 4. absence of alcohol ingestion for 2 weeks prior to study and throughout the study duration Exclusion Criteria: 1. current participation in another research protocol or unable to give informed consent 2. women with a positive urine pregnancy test or breastfeeding 3. history of inflammatory bowel disease, lactose intolerance and/or celiac sprue 4. + hydrogen breath test for bacterial overgrowth 5. + anti-endomysial antibody titer 6. use of NSAIDs 2 weeks before or during the study 7. known allergy to glutamine or whey protein 8. abdominal surgery except for removal of gallbladder, uterus, or appendix >6 months prior to entry into the study 9. Abnormal serum BUN and/or creatinine 10. Mannitol recovery out of the normal range of 5-25 U/g 11. history of kidney disease 12. allergies to monosodium glutamate 13. current use of anti-seizure medications |
Country | Name | City | State |
---|---|---|---|
United States | Memphis VA Medical Center, Memphis, TN | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine if oral glutamine supplementation will improve the Symptom Severity Scale in veterans with GWI and chronic GI Symptoms. | It's anticipated that veterans with GWI and GI symptoms will show a significant reduction, compared to placebo, in their chronic GI symptoms as reflected by their Symptom Severity Scale Score following glutamine therapy. For each participating subject, the Symptom Severity Scale score will be measured at baseline, and at 8, 12, 16, 20, and 26 weeks after the start of treatment. The investigators will have Symptom Severity Scale scores at 5 time points in each group (glutamine, placebo). These will be explored graphically with time course plots. At each time point, for Symptom Severity Scale scores, the investigators will also calculate descriptive statistics including mean and standard deviation, as well as median, median absolute deviation and inter-quartile range if the distribution of data is skewed. Box plots will be used to graphically demonstrate the distribution of Symptom Severity Scale scores at each time point. This will be done for both the glutamine and the placebo groups. | 3 years | |
Primary | To determine if oral glutamine supplementation will restore intestinal permeability in veterans with GWI. | Following our recent findings, we expect >75% of veterans will restore normal intestinal permeability, while in the placebo group, this percentage is ~6%. One sample one sided proportion test (PROC FREQ in SAS) will be used to test whether the proportion of restoration is >75% in each treatment group (glutamine supplementation or placebo) and two sample one sided proportion tests (PROC FREQ in SAS) to compare the difference between the two groups. To examine the association between the Symptom Severity Scale Score and restoration of normal intestinal permeability, Pearson's correlations between the Symptom Severity Scale and intestinal permeability will be calculated at baseline, and at 8, 12, 16, 20, and 26 weeks after the start of treatment, for both oral glutamine and placebo groups. | 3 years |
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