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A trial to assess the Efficacy of Stool Transplantation in patients suffering from Non alcoholic Steatohepatitis (NASH)

Gut microbiome and its modulation through Fecal Microbiota Transplantation (FMT) in patients with Nonalcoholic Steatohepatitis (NASH) - NIL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058394
Enrollment
50
Registered
2023-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E65- Localized adiposity

Interventions

Intervention1: Fecal Microbiota Transplantation (FMT): 100 g Fresh fecal sample taken from healthy donor added in 400 ml saline and filter its. Took 150 ml of for duodenoscopy of procedure Control In

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with NAFLD liver biopsy-proven NASH 2. Written informed consent 3. Age between 18 and 60 years 4. Non-Cirrohtic 5. Any BMI

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. Patients on drugs are known to be associated with fatty liver 2. Antituberculosis drugs 3. Alcohol consumption ( >21 standard drinks per week in men and >14 standard drinks per week in women)(1) 4. Pregnant women 5. Other etiology of chronic liver diseases such as hepatitis C, Wilsonâ??s disease, autoimmune liver disease, alpha-1-antitrypsin deficiency, or Hemochromatosis. 6. Diabetes 7. Recent antibiotic use within the last 1 month 8. Probiotic intake, any gastric surgery

Design outcomes

Primary

MeasureTime frame
In the first step of the study, patients with NASH and no-NASH will be compared to understand the differences in the gut microbiome composition in the 2 groups ( 50 Patients of each group) through one YearsTimepoint: baseline and 1 year

Secondary

MeasureTime frame
The objective of fecal microbiota transplant (FMT) in lean & non-lean NAFLD is to restore a healthy gut microbiota & potentially improve the clinical outcomes of NAFLD.Timepoint: baseline & 1 year

Countries

India

Contacts

Public ContactBipin Tiwari

AIIMS Delhi

drshalimar@gmail.com9868397211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026