Effect of Multiple healthy donor intestinal microbiota infusions on non Alcoholic Steatosis Hepatis (NASH) and vascular function; the MASH trial
Recruiting
- Conditions
- AFLD/NASH
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 54
Inclusion Criteria
Patients: obese subjects (BMI > 25 kg/m2, male or postmenopausal female subjects aged 21-69 years old without concomitant medication) with biopsy-proven NASH
Exclusion Criteria
Patients:
- history of cardiovascular disease, Cholecystectomy, heavy alcohol use or immunodeficiency;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome parameter is reversal of steatosis hepatis without worsening of fibrosis, as assessed by liver biopsy using the Brunt classicification between baseline and after 6 months
- Secondary Outcome Measures
Name Time Method -changes in (small) intestinal microbiota and bacterial translocation after fecal transplantation<br /><br>- changes in MRI based liver and vascular wall imaging after fecal transplantation<br /><br>- changes in plasma (monocyte) and subcutaneous adipose tissue inflammatory markers after fecal transplantation<br />