FMT for Alcohol Use Disorder in Cirrhotics.
FMT for Alcohol Use Disorder in Cirrhotics: A Randomized Controlled Trial.
Institute of Liver and Biliary Sciences, India
54 participants
Jul 27, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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).
Exclusion Criteria14
- 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.
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Interventions
\- Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4
Baclofen + AUD counselling
Placebo identical to the FMT arm.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06496191