CClinicalTrials.gg
Sign In
RecruitingNCT06496191Updated Jul 30, 2024

FMT for Alcohol Use Disorder in Cirrhotics.

An interventional study of FMT and SMT in Liver Cirrhosis, sponsored by Institute of Liver and Biliary Sciences, India. Recruiting at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Liver Cirrhosis
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 54 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • 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.

    Biological: FMT · Other: SMT

  • Active comparator
    Placebo + SMT

    Placebo therapy with SMT (Baclofen + AUD counselling)

    Other: SMT · Other: Placebo

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.

06

What researchers measure

Primary outcomes

  1. Proportion of patients achieving and maintaining alcohol abstinence at 4 weeks

    Time frame: 4 weeks

Secondary outcomes

  1. Gut microbiome alterations and relative abundance of gut associated bacteria.

    Gut microbiome composition will be assessed by 16s Metagenomics

    Time frame: 12 weeks

  2. Proportion of patients who got FMT at 12 weeks without liver related adverse effects compared to placebo.

    Time frame: 12 weeks

  3. Proportion of patients maintaining abstinence from alcohol at 3 & 6 months.

    Time frame: 3 and 6 months

  4. Craving measures will be assessed based on pre-existing structured and validated questionnaires (Obsessive Compulsive Drinking Scale (OCDS) and Visual Analog Scale (VAS).

    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)

    Time frame: 4,12 weeks and 6 months

  5. Proportion of patients developing lapse and relapse at 4,12 weeks and 6 months.

    Time frame: 4,12 weeks and 6 months.

07

Study locations

1 of 1 sites recruiting
  • Institute of Liver & Biliary Sciences (ILBS)
    New Delhi, Delhi 110070, India
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06496191
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Jul 11, 2024
Start date
Jul 27, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jul 30, 2024

Study contacts

Dr Srajit Singh, MD
Contact
srajitsinghparmar@gmail.com
01146300000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Liver Cirrhosis→

Other studies from this sponsor

Institute of Liver and Biliary Sciences, India

Start the discussion