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Fiber supplements for gut bacteria in people with cirrhosis and PTSD

Tests potato starch or cellulose fiber supplements in adults with cirrhosis and PTSD.

Key facts

Who runs it
Hunter Holmes Mcguire Veteran Affairs Medical Center
Where
Richmond, United StatesSee the site
Trial code
Registry title
Microbiome Modulation With Prebiotics in PTSD and Cirrhosis
Status
Recruiting
People taking part
30 people, planned
Started
31 Jul 2024
Expected to end
25 Sept 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Resistant potato starch
  • Powdered cellulose
Record updated
9 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with both cirrhosis (liver scarring) and PTSD. It tests resistant potato starch against cellulose powder taken as a supplement.

Age
Over 18 years
Sex
All sexes
Disease stage
A diagnosis of cirrhosis. PTSD that meets the PCL-5 questionnaire definition and is recorded in the medical chart by a mental health provider.
Earlier treatment
No prebiotics, probiotics (including yogurt with live probiotics), postbiotics, fiber supplements, systemic antibiotics, fecal microbiota transplant, anti-diarrheal drugs, stool softeners or immune-changing drugs in the last 30 days. No current treatment for hepatic encephalopathy (brain problems caused by liver disease).

Main reasons for not taking part

  • Known SARS-CoV-2 infection in the last 60 days
  • Alcohol abuse (more than 14 drinks per week for men, 7 for women) or active illegal drug use (marijuana is allowed)
  • Pregnant, breastfeeding or planning pregnancy during the study
  • Inflammatory bowel disease, Crohn's disease, Celiac disease, or past gut surgery
  • Unstable psychiatric illness (psychosis) or trouble swallowing

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • Age >18 years
  • Ability to provide informed written consent
  • Cirrhosis diagnosis
  • Willing to comply with all study procedures and be available for the duration of the study
  • Ability to take oral medication
  • Willing to provide study-related samples
  • Meeting the PCL-5 definition of PTSD and have a chart diagnosis of PTSD made by a mental health provider

Who cannot take part

  • Active illicit drug use (marijuana is allowed)
  • Use of investigational drugs, biologics, or devices within 30 days prior to randomization
  • Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
  • Fecal microbiota transplant in the last 30 days
  • Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days
  • Known SARS-CoV-2 infection in the last 60 days using medical records
  • Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac disease
  • Unstable psychiatric illness (psychosis)
  • Allergies to any of the ingredients in assigned products
  • Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results
  • Subjects identified as, or appearing to, lack consent capacity
  • Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)
  • Individuals who are pregnant, lactating or planning on becoming pregnant during the study
  • Use of other prebiotics, probiotics (including yogurt containing live probiotics), postbiotics, or other fiber supplements in the last 30 days
  • Systemic antibiotics in the last 30 days
  • Active dysphagia
  • On treatment for hepatic encephalopathy

Where in United States

  • Hunter Holmes McGuire VA Medical CenterRichmond, United StatesContact: Jasmohan S Bajaj, MDTaking people

About the trial

What the trial wants to find out

Despite medical advancements, PTSD remains a major issue in Veterans1. Current treatment strategies have relatively poor adherence. In patients with PTSD and cirrhosis, there is greater cognitive impairment as well as changes in gut microbiome structure and function2,3. In addition, when there is concomitant cirrhosis, medication-related treatment options become even narrower from a safety and tolerability perspective and cognitive issues pertaining to cirrhosis could impact participation3. Changes in gut microbiome in Veterans with cirrhosis and PTSD compared to those with cirrhosis without PTSD is characterized by a greater relative expression of pathobionts and reduction in stool microbiome diversity with reduction in bacteria that produce beneficial short chain fatty acids (SCFA)2. Modulation of the gut microbiome in patients with cirrhosis and PTSD may be an important therapeutic target. In prior studies with cirrhosis alone, microbial modulation using diet, antibiotics such as rifaximin, probiotics, and fecal microbiota transplant have improved gut microbial diversity and clinical outcomes in some cases4,5. In patients with cirrhosis without PTSD and in patients with PTSD without cirrhosis there is emerging evidence regarding prebiotics and other forms of gut microbial modulation.

Read full original descriptionShow less

Prebiotics are such an example6. Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota (good bacteria in the gut)6. Resistant starches (RS) are dietary fiber prebiotics found naturally in many foods including potatoes, plantains, and legumes6,7. In addition to being highly accessible, RS have been shown to be well tolerated with few adverse reactions. While no studies of RS exist in PTSD + cirrhosis patients, a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found7. However, there is insufficient data regarding patients with PTSD and cirrhosis regarding gut microbial structure and function modulation with dietary supplements such as resistant starches. These starches can improve SCFA production in elderly subjects, which could in turn affect the gut-brain axis favorably8.

The 2 groups in the trial

  • Resistant potato starchTreatment being tested
  • CelluloseExisting treatment, for comparison

    Treatment: Powdered cellulose

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Structure and Function of Microbiome Change in Subjects With Cirrhosis and PTSD After Potato Starch or Cellulose Supplementation (RESIST-PTSD)
Plain-language title
Fiber supplements for gut bacteria in people with cirrhosis and PTSDGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
9 April 2026