RECRUITING

Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Conditions

Liver Disease; Alcohol-Related Cirrhosis Alcohol Use Disorder Intestinal Microbiota Transplant Chronic Liver Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-21

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05548452

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Jasmohan S Bajaj, MD

CONTACT

804 675 5802

jasmohan.bajaj@vcuhealth.org

Amy Bartels, BSN, RN

CONTACT

804-828-3849

Amy.Bartels1@vcuhealth.org

Principal Investigator

Jasmohan S Bajaj, MD

PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Study Locations (Sites)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249

United States

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

Jasmohan S Bajaj, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-21

Study Completion Date2026-12

Study Record Updates

Study Start Date2022-11-21

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Intestinal Microbiota Transplant
Alcohol Use Disorder
Cirrhosis
Chronic Liver Disease

Additional Relevant MeSH Terms

Liver Disease; Alcohol-Related
Cirrhosis
Alcohol Use Disorder