NCT06496191

FMT for Alcohol Use Disorder in Cirrhotics.

FMT for Alcohol Use Disorder in Cirrhotics: A Randomized Controlled Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

* Title "FMT for Alcohol Use Disorder in cirrhotics: A Randomized Controlled Trial" * The aim of the study is to study the efficacy of Fecal microbiota transplantation in patients with Alcohol liver disease over a 6 month duration without liver related side effects. The project will be conducted at ILBS over the period of 1 year. * The concept is to test the efficacy of FMT in alcohol related cirrhotics by its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.

Detailed description

Hypothesis :- - FMT is useful in reducing craving and return to heavy drinking in patients with alcohol related cirrhosis with active drinking, through modulation of gut microbiota and correction of dysbiosis Aim and Objective - \- To assess the efficacy of FMT in decreasing lapse, relapses and maintaining alcohol abstinence in AUD in patients with cirrhosis Study population: \- Patients with cirrhosis with recent alcohol use attending outpatient clinic at ILBS, New Delhi Study design: \- Open label, parallel group, randomized, controlled study. Study period: \- 1 year Sample size with justification: \- Assuming that abstinence in Placebo group is 50% and we assume that there will be 40% absolute increase in FMT group (90%; Bajaj JS, Hepatology 2021) with alpha 5 and power of 80%, investigator need to enroll 48 cases, further assuming 10 % dropout rate it was decided to enroll 54 cases that is 27 in each group.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	FMT	\- Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4
OTHER	SMT	Baclofen + AUD counselling
OTHER	Placebo	Placebo identical to the FMT arm.

Timeline

• Start date: 2024-07-27
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-07-11
• Last updated: 2024-07-30

Locations

1 site across 1 country: India