Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2024-07-27
2025-06-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
FMT
\- Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4
SMT
Baclofen + AUD counselling
Placebo + SMT
Placebo therapy with SMT (Baclofen + AUD counselling)
SMT
Baclofen + AUD counselling
Placebo
Placebo identical to the FMT arm.
Interventions
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FMT
\- Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4
SMT
Baclofen + AUD counselling
Placebo
Placebo identical to the FMT arm.
Eligibility Criteria
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Inclusion Criteria
2. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).
Exclusion Criteria
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.
18 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS-FMT-03
Identifier Type: -
Identifier Source: org_study_id
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