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Could a potato starch supplement help veterans with liver disease and PTSD?

NCT ID NCT06464952

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a prebiotic called resistant potato starch can change the gut microbiome in 30 veterans who have both cirrhosis (liver scarring) and PTSD. Participants will take either the potato starch or a placebo (cellulose) for a period, and researchers will measure changes in gut bacteria diversity and bile acids. The goal is to understand if this simple supplement can improve gut health, which might eventually help with brain function and PTSD symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
resistant potato starch
What this could lead to
If successful, this could point toward a simple dietary supplement to improve gut health and possibly brain function in people with cirrhosis and PTSD.
What could go wrong
This is a very small, early-stage study with only 30 participants, so results may not apply widely. It is designed to observe changes, not to prove a treatment works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hunter Holmes McGuire VA Medical Center

    RECRUITING

    Richmond, Virginia, 23249, United States

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