Mechanisms of Gulf War Illness

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
VA Office of Research and Development
Study ID
NCT05972291
Status
Recruiting
Apply to this trial

Conditions

  • Gastrointestinal Symptoms
  • Gulf War Illness
  • Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral Glutamine — DIETARY_SUPPLEMENT
    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.
  • Control Arm — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 16, 2023
Status verified
Nov 2025
Primary completion
Jul 30, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Glutamine
    You will be asked to consume 5 grams of glutamine three times a day for 12 weeks. At week four, you will be asked to return to the CRC to be assessed, and then to return every four weeks until week 12, which will be the conclusion of the study.
  • Placebo Comparator: Whey Protein Powder
    You will be asked to consume 5 grams of whey protein powder three times a day for 12 weeks. At week four, you will be asked to return to the CRC to be assessed, and then to return every four weeks until week 12, which will be the conclusion of the study.

Primary Outcome Measure

To determine if oral glutamine supplementation will improve the Symptom Severity Scale in Veterans with GWI and chronic GI Symptoms. [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memphis VA Medical Center, Memphis, TNMemphisTennessee38104-2127
George N Verne
[email protected]
901-523-8990
Sue A Theus, PhD
[email protected]
(901) 523-8990
George N Verne (PRINCIPAL_INVESTIGATOR)
QiQi Zhou, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Memphis VA Medical Center, Memphis, TN· Memphis, TN

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