MedTrace Logo

FMT for Alcohol Use Disorder in Cirrhotics.

NCT06496191 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-07-30

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-27
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06496191 on ClinicalTrials.gov