Mechanisms of Gulf War Illness
VA Office of Research and Development
80 participants
Oct 16, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating) that started during their deployment in the Persian Gulf
- Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating)
- increased intestinal permeability on the lactulose/mannitol permeability test (ratio \>0.07)
- able and willing to cooperate with the study
Exclusion Criteria13
- current participation in another research protocol or unable to give informed consent
- women with a positive urine pregnancy test or breastfeeding
- history of inflammatory bowel disease, lactose intolerance and/or celiac sprue
- \+ hydrogen breath test for bacterial overgrowth
- \+ anti-endomysial antibody titer
- use of NSAIDs 2 weeks before or during the study
- known allergy to glutamine or whey protein
- abdominal surgery except for removal of gallbladder, uterus, or appendix \>6 months prior to entry into the study
- Abnormal serum BUN and/or creatinine
- Mannitol recovery out of the normal range of 5-25 U/g
- history of kidney disease
- allergies to monosodium glutamate
- current use of anti-seizure medications
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Interventions
You will receive an unmarked packet with either glutamine or whey protein powder. Once the packet is opened, the powder should be mixed completely with 8 oz of water. You should completely drink this mixture within 10 minutes. You will consume one packet three times a day for 12 weeks. One packet 30 minutes before breakfast, one packet 30 minutes before lunch, and one packet 30 minutes before the evening meal.
You will receive an unmarked packet with either glutamine or whey protein powder. Once the packet is opened, the powder should be mixed completely with 8 oz of water. You should completely drink this mixture within 10 minutes. You will consume one packet three times a day for 12 weeks. One packet 30 minutes before breakfast, one packet 30 minutes before lunch, and one packet 30 minutes before the evening meal.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05972291