Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05972291

Mechanisms of Gulf War Illness: A Randomized Trial of Oral Glutamine Supplementation for Chronic Gastrointestinal Symptoms in Veterans

Led by VA Office of Research and Development · Updated on 2025-12-05

80

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating chronic gastrointestinal symptoms in veterans with Gulf War Illness (GWI) who served in the Persian Gulf. These symptoms, including diarrhea, bloating, and abdominal pain, affect up to one-third of veterans with GWI and cause significant health and economic impacts. The study aims to explore whether oral glutamine supplementation can improve these symptoms by restoring intestinal permeability, which has been shown to be increased in affected veterans. Participants will be randomly assigned to receive either oral glutamine or a placebo of whey protein powder. Both treatments involve consuming 5 grams of the powder mixed with water three times daily for 12 weeks, taken 30 minutes before meals. Assessments occur at baseline, week 4, and every four weeks until the study concludes at week 12. During the study, veterans will complete symptom severity assessments and tests measuring intestinal permeability. Researchers will monitor their response to treatment and adherence to the dosing schedule. The primary outcomes focus on changes in symptom severity and intestinal permeability over three years. The study is sponsored by the VA Office of Research and Development and excludes individuals with certain medical conditions or current conflicting treatments.

CONDITIONS

Brief Title

Mechanisms of Gulf War Illness

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans aged 18 to 65 years with Gulf War Illness and chronic gastrointestinal symptoms (abdominal pain, diarrhea, bloating) that began during deployment in the Persian Gulf
  • Veterans aged 18 to 65 years with Gulf War Illness and chronic gastrointestinal symptoms
  • Increased intestinal permeability on the lactulose/mannitol permeability test (ratio >0.07)
  • Able and willing to cooperate with the study
Not Eligible

You will not qualify if you...

  • Current participation in another research protocol or inability to give informed consent
  • Women with a positive urine pregnancy test or who are breastfeeding
  • History of inflammatory bowel disease, lactose intolerance, or celiac sprue
  • Positive hydrogen breath test for bacterial overgrowth
  • Positive anti-endomysial antibody titer
  • Use of NSAIDs within 2 weeks before or during the study
  • Known allergy to glutamine or whey protein
  • Abdominal surgery except removal of gallbladder, uterus, or appendix more than 6 months before study entry
  • Abnormal serum BUN or creatinine levels
  • Mannitol recovery outside normal range of 5-25 U/g
  • History of kidney disease
  • Allergy to monosodium glutamate
  • Current use of anti-seizure medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants consume an unmarked packet containing either glutamine or whey protein powder three times a day for 12 weeks. The powder should be mixed with water and consumed 30 minutes before each meal.

Visits at week 4, week 8, and week 12 (in-person)

Trial Site Locations

Total: 1 location

1

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, United States, 38104-2127

Actively Recruiting

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Research Team

G

George N Verne

Q

QiQi Zhou, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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