Status:
RECRUITING
Mechanisms of Gulf War Illness
Lead Sponsor:
VA Office of Research and Development
Conditions:
Gulf War Illness
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
Since 2001, more than 2.2 million US veterans have served in Operation Enduring Freedom (OEF) in Afghanistan and Operation Iraqi Freedom (OIF) in Iraq. The Gulf Registry of the VA Environmental Epidem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05972291
Start Date
October 16 2023
End Date
July 31 2027
Last Update
December 5 2025
Active Locations (1)
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1
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, United States, 38104-2127