Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05972291

Conditions

Gulf War Illness

Irritable Bowel Syndrome

Gastrointestinal Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Oral Glutamine

Control Arm

Study Details

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 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.

Conditions

Gulf War Illness

Irritable Bowel Syndrome

Gastrointestinal Symptoms

Study ID

NCT05972291

Start date

Oct 16, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Oral Glutamine

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

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.

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 ]
  • To determine if oral glutamine supplementation will restore intestinal permeability in Veterans with GWI. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

George N Verne

(901) 523-8990George.Verne@va.gov

QiQi Zhou, MD PhD

(901) 523-8990qiqi.zhou@va.gov

Locations

Memphis VA Medical Center, Memphis, TN

Recruiting

Memphis, Tennessee, United States, 38104-2127

Contacts

George N Verne

(901) 523-8990George.Verne@va.gov

Sue A Theus, PhD

(901) 523-8990sue.theus@va.gov

Principal Investigator:

George N Verne

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • gastrointestinal
  • irritable bowel syndrome
  • glutamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-19.