Transplanting gut bacteria to treat alcohol-related liver disease
Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
This study is testing if taking gut bacteria capsules from healthy people can help reduce alcohol cravings and drinking in patients with liver disease caused by alcohol.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 2 sites (Richmond, Virginia and 1 other locations) |
| Trial ID | NCT05548452 on ClinicalTrials.gov |
What this trial studies
This research evaluates the safety and effectiveness of intestinal microbiota transplant (IMT) capsules derived from healthy individuals to help reduce alcohol cravings and consumption in patients with alcohol-associated liver disease. Participants will be randomly assigned to receive either the IMT capsules or a placebo over a period of up to 7 months, with multiple visits to the medical center for assessments and data collection. The study aims to gather comprehensive health information and monitor changes in liver function and alcohol use behaviors.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with advanced liver disease caused by alcohol and a history of sustained drinking.
Not a fit: Patients who have recently experienced alcoholic hepatitis or those with significant mood disorders or psychotic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for individuals struggling with alcohol use disorder and related liver disease.
How similar studies have performed: While the use of microbiota transplants is a novel approach in this context, similar studies have shown promise in other areas of treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Richmond, Virginia and 1 other locations
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Jasmohan S Bajaj, MD — Virginia Commonwealth University
- Study coordinator: Jasmohan S Bajaj, MD
- Email: jasmohan.bajaj@vcuhealth.org
- Phone: 804 675 5802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.