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Could a poop pill curb alcohol cravings in liver disease patients?

NCT ID NCT05548452

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 4 times

Summary

This study tests whether capsules containing bacteria from healthy people can safely reduce alcohol cravings and drinking in adults with alcohol-related liver disease and cirrhosis. About 80 participants will receive either the bacteria capsules or a placebo, and researchers will track drinking days, cravings, and liver health over several months. The goal is to see if changing gut bacteria can help people drink less and improve their liver condition.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 80 people

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

Started

Nov 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: -\>18 years of age * Advanced liver disease * Able to give written, informed consent * Alcohol as a cause of advanced liver disease * Continued sustained drinking * Having previously declined a referral to traditional AUD therapy services or having failed such treatments Exclusion Criteria: * Lack of sustained drinking * Recent or current alcoholic hepatitis * Alcohol withdrawal symptoms * Clinically significant use of illicit drugs * Uncontrolled mood disorders or primary psychotic conditions * MELD score\>17 * Unclear diagnosis of chronic liver disease * Current hepatic encephalopathy on lactulose and/or rifaximin * WBC count\<1000 * Non-elective hospitalization within last month * on dialysis * known untreated, in-situ luminal GI cancers * chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease) * Dysphagia within 2 weeks * History of aspiration, gastroparesis, intestinal obstruction * Ongoing absorbable antibiotic use * Severe anaphylactic food allergy * allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil) * Adverse event attributable to prior IMT * ASA Class IV or V * Pregnant or nursing patients * acute illness or fever on the day of planned FMT * Immunosuppression * Other conditions which make patients are poor candidate for this study per investigator judgement

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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.

Contacts and locations

Locations

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

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Other studies related to the condition(s) this trial covers.