Status:
RECRUITING
FMT for Alcohol Use Disorder in Cirrhotics.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 d...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06496191
Start Date
July 27 2024
End Date
June 30 2025
Last Update
July 30 2024
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070