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Gut bacteria capsules may stop liver-related brain fog in veterans

NCT ID NCT07528690

Prevention Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether capsules containing gut microbes from healthy people can prevent future episodes of hepatic encephalopathy (a brain condition caused by liver problems) in 162 veterans with cirrhosis. Participants will take the capsules and be monitored for hospital visits or medication changes. The goal is to find a new way to stop this serious complication from coming back.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 162 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

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

21 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: * 21 years of age * Cirrhosis diagnosed by any of the following in a patient with chronic liver disease * Liver Biopsy * Radiologic evidence of varices, cirrhosis or portal hypertension * Laboratory evidence of platelet count \<110,000 or AST/ALT ratio\>1 * Endoscopic evidence of varices or portal hypertensive gastropathy * Prior overt HE (patient can be on lactulose and/or rifaximin 4 weeks stable dosing) * Able to give written, informed consent \[mini-mental status exam (MMSE)\]\>25 at the time of consenting) * For lactulose only group: Prior HE not on rifaximin Exclusion Criteria: * Disease-related: * MELD3.0 score\>22 * WBC count\<1000 * non-elective hospitalization or overt HE episode within 1 month * on dialysis * known untreated, luminal GI cancer * chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease, microscopic colitis, eosinophilic gastroenteritis or celiac disease) * Safety-related: * Current dysphagia * History of aspiration, intestinal obstruction or non-medication induced gastroparesis * Ongoing absorbable antibiotic use * History of anaphylactic food allergy * Allergy to ingredients in the capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil) * Adverse event attributable to prior FMT (7) ASA Class V * Pregnant or nursing patients * Acute illness or fever on the day of planned FMT * History of spontaneous bacterial peritonitis

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis hepatic encephalopathy

As listed by the trial registrant

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

Cirrhosis Hepatic encephalopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. 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

  • CERC (VISN1, West Haven, CT)

    West Haven, Connecticut, 06516-2770, United States

  • Richmond VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216-7167, United States

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