Fecal microbiota transplantation for alcohol use disorder in patients with liver cirrhosis
FMT for Alcohol Use Disorder in Cirrhotics: A Randomized Controlled Trial.
This study is testing whether a treatment using gut bacteria from healthy donors can help people with liver cirrhosis due to alcohol use stay sober and reduce their drinking relapses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT06496191 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of fecal microbiota transplantation (FMT) in patients suffering from alcohol-related liver cirrhosis. Conducted over a year at the Institute of Liver and Biliary Sciences in New Delhi, the trial will assess whether FMT can help maintain abstinence from alcohol and reduce the frequency of lapses and relapses in drinking behavior. The study will involve a randomized controlled design with participants receiving either FMT, standard medical treatment, or a placebo. The primary focus is on the modulation of gut microbiota to improve outcomes in patients with alcohol use disorder.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with alcohol-related cirrhosis and active alcohol consumption within the last four weeks.
Not a fit: Patients with severe liver dysfunction, recent antibiotic use, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve abstinence rates and overall health outcomes for patients with alcohol-related liver disease.
How similar studies have performed: While the use of FMT in this context is relatively novel, previous studies have shown promising results in related areas of gut microbiota modulation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Delhi, National Capital Territory of Delhi
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr Srajit Singh, MD
- Email: srajitsinghparmar@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.