Modulating gut microbiome with prebiotics in veterans with PTSD and cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hunter Holmes McGuire VA Medical Center
  Richmond, Virginia, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.