A trial to assess the Efficacy of Stool Transplantation in patients suffering from Non alcoholic Steatohepatitis (NASH)
Phase 2
- Conditions
- Health Condition 1: E65- Localized adiposity
- Registration Number
- CTRI/2023/10/058394
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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, Wilson’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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In the first step of the study, patients with NASH and no-NASH will be compared to understand the <br/ ><br>differences in the gut microbiome composition in the 2 groups ( 50 Patients of each group) through one YearsTimepoint: baseline and 1 year <br/ ><br>
- Secondary Outcome Measures
Name Time Method The objective of fecal microbiota transplant (FMT) in lean & non-lean NAFLD is to restore a <br/ ><br>healthy gut microbiota & potentially improve the clinical outcomes of NAFLD.Timepoint: baseline & 1 year