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NCT Number: NCT06464952

Microbiome Modulation With Prebiotics in PTSD and Cirrhosis

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.

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.

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Key information

Conditions

Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Mental Disorders PTSD Pathologic Processes Pathological Conditions, Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location status: Recruiting

Location contact

Jasmohan S Bajaj, MD

CONTACT

[email protected]

804-675-5021

Jasmohan S Bajaj, MD, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Known SARS-CoV-2 infection in the last 60 days using medical records
  • 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)
  • Active illicit drug use (marijuana is allowed)
  • Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
  • Individuals who are pregnant, lactating or planning on becoming pregnant during the study
  • Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac disease
  • Unstable psychiatric illness (psychosis)
  • Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
  • 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
  • Fecal microbiota transplant in the last 30 days
  • Active dysphagia
  • Allergies to any of the ingredients in assigned products
  • Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days.
  • On treatment for hepatic encephalopathy.
  • Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.

Treatment and study plan

Resistant Potato Starch

Dietary Supplement

Prebiotic

Powdered cellulose

Dietary Supplement

Active comparator

Primary outcomes

  1. Gut microbiome Alpha Diversity between groups

    Time frame: 8 weeks

    Shannon diversity at end of interventions between both groups

Secondary outcomes

  1. Gut microbiome Alpha Diversity within groups at study end

    Time frame: 8 weeks

    Shannon diversity at end of interventions within each group

  2. Gut microbiome Alpha Diversity within groups at mid-study

    Time frame: 4 weeks

    Shannon diversity at mid-study within each group

  3. Serum bile acids

    Time frame: 8 weeks

    Bile acid levels in serum at end of study between groups

  4. Serum bile acids

    Time frame: 8 weeks

    Bile acid levels in serum at end of study within groups compared to baseline

  5. Serum short-chain fatty acid (SCFA) levels

    Time frame: 8 weeks

    SCFA levels in serum at end of study between groups

  6. Stool short-chain fatty acid (SCFA) levels

    Time frame: 8 weeks

    SCFA levels in stool at end of study between groups

  7. Serum short-chain fatty acid (SCFA) levels

    Time frame: 8 weeks

    SCFA levels in serum at end of study within groups compared to baseline

  8. Stool short-chain fatty acid (SCFA) levels

    Time frame: 8 weeks

    SCFA levels in stool at end of study within groups compared to baseline

  9. MELD score change within group

    Time frame: 8 weeks

    MELD score within groups compared to baseline

  10. MELD score change between groups

    Time frame: 8 weeks

    MELD score between groups

  11. Adherence on assigned therapy

    Time frame: 8 weeks

    Proportion of assigned therapy taken during the entire study between groups (%)

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Registry information

Official study title

Structure and Function of Microbiome Change in Subjects With Cirrhosis and PTSD After Potato Starch or Cellulose Supplementation (RESIST-PTSD)

Acronym: RESIST-PTSD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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