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CirrhosisRESIST-PTSDNCT06464952

Microbiome Modulation With Prebiotics in PTSD and Cirrhosis

A study testing Resistant potato starch and Powdered cellulose in people with Cirrhosis and PTSD, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cirrhosis, PTSD
What is being tested?
Resistant potato starch and Powdered cellulose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
31 Jul 2024to 25 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

    Jasmohan S Bajaj, MD, 804-675-5021, jsbajaj@vcu.edu

    Jasmohan S Bajaj, MD, MSc

    Recruiting

Other trials in United States

About this study

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

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
Cirrhosis, PTSD
Being tested
Resistant potato starch, Powdered cellulose
Keywords
microbiome, prebiotic, gut-brain, liver disease
Medical subject headings
Fibrosis, Stress Disorders, Post-Traumatic, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistant potato starchDietary supplement

    Prebiotic

  • Powdered celluloseDietary supplement

    Active comparator

Study groups in NCT06464952
Study groupRoleWhat they receive
Resistant potato starchExperimentalNot described
Receives: Dietary Supplement: Resistant potato starch
CelluloseActive comparatorNot described
Receives: Dietary Supplement: Powdered cellulose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut microbiome Alpha Diversity between groups

    Shannon diversity at end of interventions between both groups

    Measured: 8 weeks

Secondary outcomes (11)

  1. Gut microbiome Alpha Diversity within groups at study end

    Shannon diversity at end of interventions within each group

    Measured: 8 weeks

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

    Shannon diversity at mid-study within each group

    Measured: 4 weeks

  3. Serum bile acids

    Bile acid levels in serum at end of study between groups

    Measured: 8 weeks

  4. Serum bile acids

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

    Measured: 8 weeks

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

    SCFA levels in serum at end of study between groups

    Measured: 8 weeks

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

    SCFA levels in stool at end of study between groups

    Measured: 8 weeks

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

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

    Measured: 8 weeks

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

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

    Measured: 8 weeks

  9. MELD score change within group

    MELD score within groups compared to baseline

    Measured: 8 weeks

  10. MELD score change between groups

    MELD score between groups

    Measured: 8 weeks

  11. Adherence on assigned therapy

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start31 Jul 2024
  3. Primary completion25 Jun 2027 (estimated)
  4. Study completion25 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
RCT in patients with cirrhosis and PTSD focused on feasibility and safety
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464952
Sponsor's protocol ID
BAJAJ0036
Acronym
RESIST-PTSD
Status last verified
Apr 2026
First submitted
13 Jun 2024
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Resistant potato starch and Powdered cellulose in people with Cirrhosis and PTSD, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut microbiome Alpha Diversity between groups (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06464952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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