Modulating gut microbiome with prebiotics in veterans with PTSD and cirrhosis
Structure and Function of Microbiome Change in Subjects With Cirrhosis and PTSD After Potato Starch or Cellulose Supplementation (RESIST-PTSD)
This study is testing if giving prebiotics can help improve gut health and overall well-being in veterans who have both PTSD and liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunter Holmes Mcguire Veteran Affairs Medical Center Federal |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06464952 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of prebiotic interventions on the gut microbiome in veterans suffering from both PTSD and cirrhosis. It aims to explore how changes in gut microbiome structure and function may influence cognitive impairment and overall health in these patients. By using resistant potato starch and powdered cellulose, the study seeks to enhance the diversity of beneficial gut bacteria and improve patient outcomes. The research focuses on a population that faces unique challenges due to the combination of liver disease and mental health issues.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans over 18 years old who have a diagnosis of cirrhosis and meet the criteria for PTSD.
Not a fit: Patients with active substance abuse issues, unstable psychiatric conditions, or certain gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach to improve cognitive function and overall well-being in veterans with PTSD and cirrhosis.
How similar studies have performed: Previous studies have shown promise in microbial modulation for cirrhosis, but this specific approach in the context of PTSD is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18 years 2. Ability to provide informed written consent 3. Cirrhosis diagnosis 4. Willing to comply with all study procedures and be available for the duration of the study. 5. Ability to take oral medication. 6. Willing to provide study-related samples 7. Meeting the PCL-5 definition of PTSD and have a chart diagnosis of PTSD made by a mental health provider Exclusion Criteria: 1. Known SARS-CoV-2 infection in the last 60 days using medical records 2. Subjects identified as, or appearing to, lack consent capacity 3. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women) 4. Active illicit drug use (marijuana is allowed) 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 disease 8. Unstable psychiatric illness (psychosis) 9. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection) 10. Use of other prebiotics, probiotics (including yogurt containing live probiotics), postbiotics, or other fiber supplements in the last 30 days 11. Systemic antibiotics in the last 30 days 12. Fecal microbiota transplant in the last 30 days 13. Active dysphagia 14. Allergies to any of the ingredients in assigned products 15. Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days. 16. On treatment for hepatic encephalopathy. 17. Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.
Where this trial is running
Richmond, Virginia
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.