FMT for Alcohol Use Disorder in Cirrhotics.

NCT06496191 | Recruiting

• 1 other identifier: ILBS-FMT-03
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving and maintaining alcohol abstinence at 4 weeks

  4 weeks

Secondary Outcomes (5)

• Gut microbiome alterations and relative abundance of gut associated bacteria.

  12 weeks

• Proportion of patients who got FMT at 12 weeks without liver related adverse effects compared to placebo.

  12 weeks

• Proportion of patients maintaining abstinence from alcohol at 3 & 6 months.

  3 and 6 months

• Craving measures will be assessed based on pre-existing structured and validated questionnaires (Obsessive Compulsive Drinking Scale (OCDS) and Visual Analog Scale (VAS).

  4,12 weeks and 6 months

• Proportion of patients developing lapse and relapse at 4,12 weeks and 6 months.

  4,12 weeks and 6 months.

Study Arms (2)

FMT + SMT

EXPERIMENTAL

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.

Biological: FMT; Other: SMT

Placebo + SMT

ACTIVE COMPARATOR

Placebo therapy with SMT (Baclofen + AUD counselling)

Other: SMT; Other: Placebo

Interventions

FMT BIOLOGICAL

\- Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4

FMT + SMT

SMT OTHER

Baclofen + AUD counselling

FMT + SMT; Placebo + SMT

Placebo OTHER

Placebo identical to the FMT arm.

Placebo + SMT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients with alcohol related cirrhosis with serum bilirubin \<5mg/dl with an active alcohol consumption atleast within last 4 weeks aged between 18 -70yrs.
• Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Srajit Singh, MD

CONTACT

01146300000; srajitsinghparmar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 11, 2024
• Study Start: July 27, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-06

Locations

IN (1)