Gulf War Illness and Gastrointestinal Symptoms Study
This study is looking into ways to help veterans with Gulf War Illness (GWI) who also have long-lasting stomach and gut problems like abdominal pain, diarrhea, and bloating. Researchers want to see if taking oral glutamine, a dietary supplement, can improve these symptoms and help restore the gut lining (intestinal permeability). You would be given either oral glutamine or a control substance (whey protein powder) to mix with water and drink three times a day for 12 weeks. The study aims to enroll 80 participants. To join, you must be a veteran between 18 and 65 years old with GWI and chronic GI symptoms that started during your deployment, and have increased intestinal permeability as shown by a specific test.
- Study design
- This study involves 80 participants and compares oral glutamine to a control substance (whey protein powder). You would receive an unmarked packet, so you wouldn't know which one you are taking.
- What's involved
- You would drink a mixed powder three times a day for 12 weeks. The trial record does not specify other visits, procedures, or tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure improvements in symptoms and intestinal permeability at 3 years after starting the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Mechanisms of Gulf War Illness
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- QiQi Zhou, MD PhD · PRINCIPAL_INVESTIGATOR · Memphis VA Medical Center, Memphis, TN
- George N Verne · PRINCIPAL_INVESTIGATOR · Memphis VA Medical Center, Memphis, TN
Who to contact
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What this trial measures
- To determine if oral glutamine supplementation will improve the Symptom Severity Scale in Veterans with GWI and chronic GI Symptoms.3 years
It's anticipated that veterans with GWI and GI symptoms will show a significant reduction, compared to placebo, in their chronic GI symptoms as reflected by their Symptom Severity Scale Score following glutamine therapy. For each participating subject, the Symptom Severity Scale score will be measured at baseline, and at 4, 8, and 12 weeks after the start of treatment. The investigators will have Symptom Severity Scale scores at 5 time points in each group (glutamine, placebo). These will be explored graphically with time course plots. At each time point, for Symptom Severity Scale scores, the investigators will also calculate descriptive statistics including mean and standard deviation, as well as median, median absolute deviation and inter-quartile range if the distribution of data is skewed. Box plots will be used to graphically demonstrate the distribution of Symptom Severity Scale scores at each time point. This will be done for both the glutamine and the placebo groups.
- To determine if oral glutamine supplementation will restore intestinal permeability in Veterans with GWI.3 years
Following our recent findings, the investigators expect \>75% of veterans will restore normal intestinal permeability, while in the placebo group, this percentage is \~6%. One sample one sided proportion test (PROC FREQ in SAS) will be used to test whether the proportion of restoration is \>75% in each treatment group (glutamine supplementation or placebo) and two sample one sided proportion tests (PROC FREQ in SAS) to compare the difference between the two groups. To examine the association between the Symptom Severity Scale Score and restoration of normal intestinal permeability, Pearson's correlations between the Symptom Severity Scale and intestinal permeability will be calculated at baseline, and at 4, 8, and 12 weeks after the start of treatment, for both oral glutamine and placebo groups.