Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Description

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.

Conditions

Liver Disease; Alcohol-Related, Cirrhosis, Alcohol Use Disorder

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Study Overview

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Study Details

Study overview

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.

Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Condition
Liver Disease; Alcohol-Related
Intervention / Treatment

-

Contacts and Locations

Richmond

Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, United States, 23249

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Jasmohan S Bajaj, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2026-12