Liver Cirrhosis
Conditions
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 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.
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 dysbiosis 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.
Interventions
BIOLOGICALFMT
\- Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4
OTHERSMT
Baclofen + AUD counselling
OTHERPlacebo
Placebo identical to the FMT arm.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).
Exclusion criteria
1. Pregnancy 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving and maintaining alcohol abstinence at 4 weeks | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome alterations and relative abundance of gut associated bacteria. | 12 weeks | Gut microbiome composition will be assessed by 16s Metagenomics |
| Proportion of patients who got FMT at 12 weeks without liver related adverse effects compared to placebo. | 12 weeks | — |
| Proportion of patients maintaining abstinence from alcohol at 3 & 6 months. | 3 and 6 months | — |
| Craving measures will be assessed based on pre-existing structured and validated questionnaires (Obsessive Compulsive Drinking Scale (OCDS) and Visual Analog Scale (VAS). | 4,12 weeks and 6 months | VAS ranges from 0 to 10, where 0 means no craving and 10 means most craving or strongest drive to consume alcohol, in our thesis) |
| Proportion of patients developing lapse and relapse at 4,12 weeks and 6 months. | 4,12 weeks and 6 months. | — |
Countries
India
Contacts
Primary ContactDr Srajit Singh, MD
Outcome results
None listed