FMT for Alcohol Use Disorder in Cirrhotics.

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

• 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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Biological: FMT; Other: SMT; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Srajit Singh, MD; Phone Number: 01146300000; Email: srajitsinghparmar@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences (ILBS)
      • Contact: Dr Srajit Singh, MD; Phone Number: 01146300000; Email: srajitsinghparmar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
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 >5mg/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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT + 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.	Biological: FMT; - Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4; Other: SMT; Baclofen + AUD counselling
Active Comparator: Placebo + SMT; Placebo therapy with SMT (Baclofen + AUD counselling)	Other: SMT; Baclofen + AUD counselling; Other: Placebo; Placebo identical to the FMT arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving and maintaining alcohol abstinence at 4 weeks	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome alterations and relative abundance of gut associated bacteria.	Gut microbiome composition will be assessed by 16s Metagenomics	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).	VAS ranges from 0 to 10, where 0 means no craving and 10 means most craving or strongest drive to consume alcohol, in our thesis)	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.

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Liver Diseases; Fibrosis; Alcoholism; Liver Cirrhosis
• Other Study ID Numbers: ILBS-FMT-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No