Could a potato starch supplement help veterans with liver disease and PTSD?
NCT ID NCT06464952
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
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hunter Holmes McGuire VA Medical Center
RECRUITINGRichmond, Virginia, 23249, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ultrasound may replace invasive test for dangerous liver complication
- Could a wearable zapper quiet cirrhosis pain without drugs?
- A needle through the gut could replace the standard liver pressure test
- Can a personalized mix of nerve stimulation and therapy rewire the brain for better mental health?
- Can a therapist on a screen ease both trauma and pain?