Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06464952

Microbiome Modulation With Prebiotics in PTSD and Cirrhosis

Led by Hunter Holmes Mcguire Veteran Affairs Medical Center · Updated on 2026-04-09

30

Participants Needed

1

Research Sites

164 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Microbiome Modulation With Prebiotics in PTSD and Cirrhosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18 years
  • Ability to provide informed written consent
  • Diagnosis of cirrhosis
  • Willingness to comply with study procedures and availability for study duration
  • Ability to take oral medication
  • Willingness to provide study-related samples
  • Meeting the PCL-5 definition of PTSD and having a chart diagnosis of PTSD by a mental health provider
Not Eligible

You will not qualify if you...

  • Known SARS-CoV-2 infection in the last 60 days
  • Lack of consent capacity
  • Alcohol abuse (more than 14 drinks per week for men, 7 for women)
  • Active illicit drug use (marijuana allowed)
  • Use of investigational drugs, biologics, or devices within 30 days before randomization
  • Pregnancy, lactation, or planning pregnancy 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 prebiotics, probiotics, postbiotics, or other fiber supplements in last 30 days
  • Systemic antibiotics in last 30 days
  • Fecal microbiota transplant in last 30 days
  • Active dysphagia
  • Allergies to any ingredients in study products
  • Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in last 30 days
  • On treatment for hepatic encephalopathy
  • Any other condition or medication that may affect gut response or study results as judged by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States, 23249

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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