Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Liver Disease; Alcohol-Related, Cirrhosis, Alcohol Use Disorder

In brief

The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.

Key facts

Study ID

NCT05548452

Run by

Virginia Commonwealth University

People needed

80

Starts

2022-11-21

Expected to finish

2027-11-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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

You may not qualify if…

• 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

Where it is running

• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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