Mechanisms of Gulf War Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Oral Glutamine
Dietary supplementYou 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 interventionYou 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Oral GlutamineExperimental treatment 1 intervention
Group B: Whey Protein PowderPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To determine if oral glutamine supplementation will improve the Symptom Severity Scale in Veterans with GWI and chronic GI Symptoms.
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.
Time frame
3 years2
To determine if oral glutamine supplementation will restore intestinal permeability in Veterans with GWI.
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.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov