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Oral Glutamine for Gulf War Syndrome
N/A
Recruiting
Led By QiQi Zhou, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Summary
This trial will provide a novel treatment for veterans with Gulf War Illness who have chronic GI symptoms, which currently have no specific treatments. It could drastically improve the health of many veterans and reduce negative economic effects.
Who is the study for?
This trial is for veterans aged 18-65 with Gulf War Illness (GWI) and chronic GI symptoms like abdominal pain, diarrhea, or bloating that began during deployment in the Persian Gulf. Participants must show increased intestinal permeability and abstain from alcohol before and during the study. Pregnant women, those with certain medical conditions or allergies, or on specific medications cannot join.
What is being tested?
The trial is testing Oral Glutamine against a control arm to treat chronic gastrointestinal symptoms in veterans with GWI. The goal is to find an effective treatment where none currently exists, potentially improving veteran health and reducing economic strain on healthcare systems.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of glutamine may include cough or hoarseness, frequent urge to defecate, heartburn, back pain; however individual experiences can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine if oral glutamine supplementation will improve the Symptom Severity Scale in Veterans with GWI and chronic GI Symptoms.
To determine if oral glutamine supplementation will restore intestinal permeability in Veterans with GWI.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral GlutamineExperimental Treatment1 Intervention
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.
Group II: Whey Protein PowderPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,765,695 Total Patients Enrolled
QiQi Zhou, MD PhDPrincipal InvestigatorMemphis VA Medical Center, Memphis, TN
George N VernePrincipal InvestigatorMemphis VA Medical Center, Memphis, TN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I have a history of inflammatory bowel disease, lactose intolerance, or celiac disease.I have a history of kidney disease.I am currently taking medication for seizures.I have not taken NSAIDs 2 weeks before or during the study.I am a veteran aged 18-65 with chronic GI symptoms from my time in the Persian Gulf.I haven't consumed alcohol for the past 2 weeks and can avoid it during the study.I had abdominal surgery over 6 months ago, not including gallbladder, uterus, or appendix removal.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Glutamine
- Group 2: Whey Protein Powder
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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