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Intestinal Microbiota Transplant for Alcohol-Associated Liver Disease

This study is testing Intestinal Microbiota Transplant (IMT) Capsules, which contain bacteria from healthy donors, to see if they can help reduce alcohol cravings and drinking in people with alcohol-associated liver disease and cirrhosis. You might be able to join if you are over 18, have advanced liver disease caused by alcohol, and have continued drinking despite declining or failing traditional alcohol use disorder (AUD) treatments. The study will measure success by looking at the number of days you don't drink, changes in your drinking levels, and levels of a substance called Phosphatidyl Ethanol (PEth) in your body, all measured over three months after treatment. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 80 participants. You will be randomly assigned, like a coin flip, to receive either IMT Capsules or inactive placebo capsules.
What's involved
You will visit VCU medical center up to 8 times over 7 months. You will take capsules twice (at enrollment and after one month), have blood, urine, and stool collected, undergo brain function tests, keep a diary, and complete surveys.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured up to 3 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05548452

Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Virginia Commonwealth University
~80 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Intestinal Microbiota Transplant (IMT) CapsulesPlacebo Capsules

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of abstinent days
Measured over Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
+2 more outcomes measured

Conditions

Liver Disease; Alcohol-Related
Cirrhosis
Alcohol Use Disorder

Explore related trials

Alcohol use disorderCirrhosis

Where it's being run

2 sites across 1 states
Virginia2

Study leadership

  • Jasmohan S Bajaj, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\>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

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

What this trial measures

  • Number of abstinent daysBaseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)

    Number of drinks per day will be measured through self report

  • Change in WHO drinking levels by 1 or greater at month 3Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)

    WHO grade by self report

  • Phosphatidyl Ethanol (PEth) level changeBaseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)

    Change to \<70