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

Phase 2

Conditions: Health Condition 1: K703- Alcoholic cirrhosis of liver

Registration Number: CTRI/2024/07/071343

Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess proportion of patients achieving and maintaining alcohol abstinence at 4 weeksTimepoint: 4 weeks

Secondary Outcome Measures

Name	Time	Method
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