NCT05548452 Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
| NCT ID | NCT05548452 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Virginia Commonwealth University |
| Condition | Liver Disease; Alcohol-Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-11-21 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2022-11-21 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jasmohan S Bajaj, MD
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT05548452 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Disease; Alcohol-Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05548452 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05548452 currently recruiting?
Yes, NCT05548452 is actively recruiting participants. Contact the research team at jasmohan.bajaj@vcuhealth.org for enrollment information.
Where is the NCT05548452 trial being conducted?
This trial is being conducted at Richmond, United States, Richmond, United States.
Who is sponsoring the NCT05548452 clinical trial?
NCT05548452 is sponsored by Virginia Commonwealth University. The principal investigator is Jasmohan S Bajaj, MD at Virginia Commonwealth University. The trial plans to enroll 80 participants.