FMT for Alcohol Use Disorder in Cirrhotics: A Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
India
Institute of Liver & Biliary Sciences (ILBS)
RECRUITING
New Delhi
Contact Information
Primary
Dr Srajit Singh, MD
srajitsinghparmar@gmail.com
01146300000
Time Frame
Start Date: 2024-07-27
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 54
Treatments
Experimental: 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.
Active_comparator: Placebo + SMT
Placebo therapy with SMT (Baclofen + AUD counselling)
Related Therapeutic Areas
Sponsors
Leads: Institute of Liver and Biliary Sciences, India

This content was sourced from clinicaltrials.gov