Gulf War Illness Clinical Trial
Official title:
BCCMA: Targeting Gut-Microbiome in Veterans Deployment Related Gastrointestinal and Liver Diseases; CMA5- Functional Metagenomics in GWI-related Gut Dysfunction
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.
Status | Not yet recruiting |
Enrollment | 52 |
Est. completion date | August 3, 2026 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline to the end of the study period in the composition of the gut microbiome | The gut microbiome will be assessed using next generation sequencing (shotgun metagenomics) | 2 years | |
Primary | Changes from baseline to the end of the study period in the concentration of short-chain fatty acids and other metabolites identified in the gut microbiome | The metabolites in the gut will be identified through next-generation sequencing technology and both targeted and untargeted metabolomics. | 2 years | |
Secondary | Improvement in quality of life | Quality of life will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire from baseline to the end of the study period. | 2 years | |
Secondary | Changes in GWI symptoms over the study period | A GWI symptoms assessment tool will be used to determine changes in symptoms from baseline to the end of the study period. | 2 years | |
Secondary | Changes in overall health over the study period | The Veterans RAND-36 (VR-36) questionnaire will be used to determine changes in overall health and associated quality of life over the study period. | 2 years | |
Secondary | Tolerability of the probiotic defined as discontinuation due to adverse events during the study period | Assess the tolerability of orally consuming MSPrebiotic by determining the frequency of withdraws from the study due to the occurrence of adverse events. | 2 years |
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