Exploring treatments for Gulf War Illness-related gastrointestinal symptoms
Mechanisms of Gulf War Illness
This study is testing if taking glutamine can help veterans with Gulf War Illness feel better by easing their stomach problems like pain and diarrhea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT05972291 on ClinicalTrials.gov |
What this trial studies
This study investigates the chronic gastrointestinal symptoms experienced by veterans with Gulf War Illness, focusing on the potential benefits of oral glutamine supplementation. The research aims to understand the mechanisms behind these symptoms, which include abdominal pain, diarrhea, and bloating, and how glutamine may restore intestinal permeability. By conducting this trial, the investigators hope to provide a novel treatment option for veterans suffering from these debilitating symptoms, which currently lack effective therapies. The study will involve veterans aged 18-65 who meet specific eligibility criteria related to their gastrointestinal health.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18-65 with Gulf War Illness and chronic gastrointestinal symptoms that began during their deployment.
Not a fit: Patients with a history of inflammatory bowel disease, lactose intolerance, or other specified gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for veterans suffering from chronic gastrointestinal symptoms related to Gulf War Illness.
How similar studies have performed: Previous studies have shown promising results with glutamine supplementation in similar gastrointestinal conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating) 3. increased intestinal permeability on the lactulose/mannitol permeability test (ratio \>0.07) 4. able and willing to cooperate with the study 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
Where this trial is running
Memphis, Tennessee
- Memphis VA Medical Center, Memphis, TN — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: QiQi Zhou, MD PhD — Memphis VA Medical Center, Memphis, TN
- Study coordinator: George N Verne
- Email: George.Verne@va.gov
- Phone: (901) 523-8990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.