FMT for Alcohol Use Disorder in Cirrhotics.

Institute of Liver and Biliary Sciences, India

Status: Enrolling

Conditions: Liver Cirrhosis

Treatments: Other: Placebo; Biological: FMT; Other: SMT

Study type: Interventional

Funder types: Other

Identifiers

NCT06496191

ILBS-FMT-03

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

FMT + SMT

Experimental group

Description:

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.

Treatment:

Other: SMT

Biological: FMT

Placebo + SMT

Active Comparator group

Description:

Placebo therapy with SMT (Baclofen + AUD counselling)

Treatment:

Other: SMT

Other: Placebo