Actively Recruiting
BCCMA: Targeting Gut-Microbiome in Veterans Deployment Related Gastrointestinal and Liver Diseases; CMA5- Functional Metagenomics in GWI-related Gut Dysfunction
Led by VA Office of Research and Development · Updated on 2026-05-06
52
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gulf War Illness (GWI) affects about 25-32% of the more than 700,000 coalition troops deployed during the First Gulf War, causing symptoms such as pain, fatigue, gastrointestinal issues, skin problems, neurologic symptoms, and respiratory difficulties. GWI symptoms often persist without significant improvement over time, and treatments especially for gut-related symptoms are limited. This trial focuses on evaluating a dietary fiber prebiotic supplement to improve the quality of life for Veterans suffering from GWI, exploring how the gut microbiome may play a role in this condition. Participants in this phase II randomized clinical trial will be assigned to one of two groups: one group will take a resistant starch (RS) prebiotic derived from potatoes daily for four weeks, with doses increasing from 4g to 10g, while the other group will continue their usual diet without changes. The resistant potato starch is designed to improve gut microbiota by increasing beneficial bacteria and related metabolites. The study will collect stool and serum samples and use health and dietary questionnaires to monitor effects. Throughout the study, participants will provide samples and complete questionnaires to assess changes in their gut microbiome and concentrations of short-chain fatty acids. Researchers will track improvements in GWI symptoms, overall health, quality of life, and how well participants tolerate the prebiotic. The study will monitor participants over two years to evaluate both biological and clinical outcomes related to the intervention.
CONDITIONS
Brief Title
Resistant Potato Starch to Alleviate GWI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed written consent
- Willingness to comply with all study procedures and be available for the full study duration, including providing stool samples
- Meeting the modified Kansas Gulf War Illness case definition with gut symptoms
- Deployed to the Persian Gulf during Operations Desert Storm or Desert Shield
- Aged between 50 and 85 years old
You will not qualify if you...
- Known SARS-CoV-2 infection in the last 60 days or diagnosis of post-acute sequelae of COVID-19 lasting over 6 months
- Lack of consent capacity
- Alcohol abuse exceeding 14 drinks per week for men or 7 drinks per week for women
- Use of investigational drugs, biologics, or devices within 30 days prior to randomization
- Pregnancy, lactation, or planning to become pregnant during the study
- Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease
- Uncontrolled or untreated hypothyroidism
- Previous gastrointestinal surgeries such as colorectal surgery, gastric bypass, or intestinal resection
- Use of systemic antibiotics or fecal microbiota transplant in the last 30 days
- Active dysphagia
- Allergies to any ingredients in MSPrebiotic
- Use of immunomodulatory medications in the last 30 days
- Any other condition or medication that may affect gut response or study results as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants randomized to the prebiotic group consume resistant potato starch daily for 4 weeks with dose escalation. Participants in the control group maintain their usual diet during this period.
1 baseline visit and 1 follow-up visit
Duration - Up to 2 years
Participants are monitored for changes in gut microbiome composition, concentrations of short-chain fatty acids, GWI symptoms, quality of life, overall health, and tolerability of the prebiotic for up to 2 years after treatment.
Periodic visits as scheduled over 2 years
Trial Site Locations
Total: 1 location
1
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705-2254
Actively Recruiting
Research Team
N
Nasia Safdar, MD PhD
J
Julie A Keating, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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