Use of FMT (stool therapy) for Alcohol Use Disorder in patients with Liver Disease.

Fecal Microbiota Transplant for Alcohol Use Disorder in Cirrhotics: A Randomized Controlled Trial. - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071343

Enrollment

Registered

2024-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K703- Alcoholic cirrhosis of liver

Interventions

Intervention1: FMT with SMT: Therapy with Fecal microbiota transplantation with SMT (Baclofen + AUD counselling). - Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4.

Eligibility

Inclusion criteria

Inclusion criteria: 1. All consecutive patients with alcohol related cirrhosis with serum bilirubin less than 5mg per dl with an active alcohol consumption atleast within last 4 weeks aged between 18 -70yrs. 2. Fulfilling DSM – 5 criteria for alcohol use disorder (Association, 2013)

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Acute illness or fever on the day of planned FMT 3. Ongoing/Past 2 weeks antibiotic use 4. Unclear diagnosis of CLD 5. Non-elective hospitalization within last month 6. Serum bilirubin more than 5mg per dl 7. Grade 2 or more Ascites 8. Any Episode of HE Grade 2 or more or requiring hospital admission within 3 months 9. Episode of AVB within last 3 months 10. Treatment with corticosteroids/Immunosupression within the past 60 days 11. Unwilling to participate 12. Dependence on any other substance (except Nicotine) 13. Psychiatric disorder requiring pharmacotherapy/Suicidal tendency 14. Known untreated, in-situ luminal GI cancers & chronic intrinsic GI diseases

Design outcomes

Primary

Measure	Time frame
To assess proportion of patients achieving and maintaining alcohol abstinence at 4 weeksTimepoint: 4 weeks	—

Secondary

Measure	Time frame
Changes in microbiota and mucosal composition and diversity at 12 weeks.Timepoint: 12 weeks;To assess difference in craving measures between groups at 4,12 weeks and 6 monthsTimepoint: 4,12 weeks and 6 months;To assess proportion of patients developing lapse and relapse at 4,12 weeks and 6 months.Timepoint: 4,12 weeks and 6 months;To assess proportion of patients maintaining abstinence from alcohol at 3 & 6 months.Timepoint: 3 & 6 months;To assess proportion of patients who got FMT at 12 weeks without liver related adverse effects compared to placebo.Timepoint: 12 weeks	—

Measure

Time frame

Changes in microbiota and mucosal composition and diversity at 12 weeks.Timepoint: 12 weeks;To assess difference in craving measures between groups at 4,12 weeks and 6 monthsTimepoint: 4,12 weeks and 6 months;To assess proportion of patients developing lapse and relapse at 4,12 weeks and 6 months.Timepoint: 4,12 weeks and 6 months;To assess proportion of patients maintaining abstinence from alcohol at 3 & 6 months.Timepoint: 3 & 6 months;To assess proportion of patients who got FMT at 12 weeks without liver related adverse effects compared to placebo.Timepoint: 12 weeks

—

Countries

India

Contacts

Public ContactDr Vinod Arora

Institute of Liver and Biliary Sciences

VINOD_UCMS@yahoo.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026