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RECRUITING

NCT05820893

PHASE2

Resistant Potato Starch to Alleviate GWI

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

Gulf War Illness (GWI) affects an estimated 25-32% of the over 700,000 coalition troops deployed to the Persian Gulf as part of the First Gulf War. GWI causes a range of pain, fatigue, gastrointestinal, skin, neurologic, and respiratory symptoms. New treatments to reduce GWI-associated morbidity are critically needed. Research suggests a role for the gastrointestinal microbiome in mediating health, including through impacting metabolism and immunity. The disruption of this microbiome plays a role in multiple diseases, and preliminary data suggest that Veterans with GWI have altered gut microbiota. The investigators will evaluate the effectiveness of a dietary fiber prebiotic supplement intervention on improving the quality of life of Veterans with GWI.

Official title: BCCMA: Targeting Gut-Microbiome in Veterans Deployment Related Gastrointestinal and Liver Diseases; CMA5- Functional Metagenomics in GWI-related Gut Dysfunction

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-03

Completion Date

2028-06-30

Last Updated

2026-02-09

Healthy Volunteers

Conditions

Gulf War Illness

Interventions

DRUG

Resistant Potato Starch

MSPrebiotic (MSPrebiotic Inc, Carberry, Manitoba, Canada). MSPrebiotic is an unmodified resistant starch derived from potatoes (Solanar tuberosum). It consists of 20% amylose and 80% amylopectin forming granules the stomach and small intestine are unable to digest allowing for absorption in the colon. MSPrebiotic is consumed by mixing 10g into cold or room temperature foods or beverages; it is not to be heated. Participants will be instructed to take MSPrebiotic 2 or more hours before or after consuming any medications.

Inclusion Criteria: 1. Ability to provide informed written consent 2. Willing to comply with all study procedures and be available for the duration of the study. 3. Ability to take oral medication. 4. Willing to provide blood and stool samples 5. Meeting the modified Kansas GWI case definition\* with gut symptoms endorsed 6. Aged 45-80 years old * Moderate to severe GWI symptoms lasting at least 6 months in a minimum of three of the six symptom domains (one of which must be fatigue). The symptom domains are: * Pain (joint pain, muscle pain) * Gastrointestinal (diarrhea, nausea, vomiting, cramping) * Respiratory (persistent cough, wheezing) * Skin (rashes) * Fatigue (sleep problems, fatigue) * Neurologic (memory problems, headaches, dizziness, mood changes) Exclusion Criteria: 1. A Known SARS-CoV-2 infection in the last 60 days and/or with a diagnosis of post-acute sequelae of COVID-19 (PASC, sometimes called long COVID) defined as COVID-19 symptoms lasting for greater than 6 months. 2. Subjects identified as, or appearing to, lack consent capacity 3. Current smokers 4. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women) 5. Use of investigational drugs, biologics, or devices within 30 days prior to randomization. 6. Individuals who are pregnant, lactating or planning on becoming pregnant during the study. 7. Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease 8. Hypothyroidism 9. Unstable psychiatric illness 10. Involvement in another clinical trial 11. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection) 12. Use of other prebiotics, probiotics (including yogurt containing live probiotics), postbiotics, or other fiber supplements in the last 30 days 13. Systemic antibiotics in the last 30 days 14. Fecal microbiota transplant in the last 30 days 15. Active dysphagia 16. Allergies to any of the ingredients in MSPrebiotic 17. Individuals with a Kansas criteria exclusionary condition: lupus, multiple sclerosis, schizophrenia, active cancer treatment, physical impairment related to a stroke, uncontrolled Diabetes Mellitus 18. Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days. 19. The use of proton pump inhibitors, H2 receptor blockers or any other medication known to suppress gastric acid in the last 30 days. 20. Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.

Locations (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States