Actively Recruiting
FMT for Alcohol Use Disorder in Cirrhotics.
Led by Institute of Liver and Biliary Sciences, India · Updated on 2024-07-30
54
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
FMT for Alcohol Use Disorder in Cirrhotics.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with alcohol related cirrhosis with serum bilirubin less than 5 mg/dl
- Active alcohol consumption within the last 4 weeks
- Age between 18 and 70 years
- Meet DSM-5 criteria for alcohol use disorder
You will not qualify if you...
- Pregnant women
- Acute illness or fever on the day of planned FMT
- Antibiotic use within the past 2 weeks
- Unclear diagnosis of chronic liver disease
- Non-elective hospitalization within the last month
- Serum bilirubin greater than 5 mg/dl
- Grade 2 or more ascites
- Hepatic encephalopathy grade 2 or higher, or requiring hospital admission within 3 months
- Episode of acute variceal bleeding within last 3 months
- Treatment with corticosteroids or immunosuppression within past 60 days
- Unwillingness to participate
- Dependence on substances other than nicotine
- Psychiatric disorders requiring medication or suicidal tendencies
- Known untreated luminal gastrointestinal cancers or chronic intrinsic gastrointestinal diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070
Actively Recruiting
Research Team
D
Dr Srajit Singh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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