NAFLD/NASH
Conditions
Interventions
multiple lean (preferably vegetarian/vegan) donor fecal transplantations
Sponsors
AMC
Eligibility
Inclusion criteria
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 Donors:lean (BMI 20-25k/gm2) preferably vegan/vegetarian male / postmenopausal female subjects, Aged 21 to 69 years , no concomitant medication,
Exclusion criteria
Exclusion criteria: Patients: - history of cardiovascular disease, Cholecystectomy, heavy alcohol use or immunodeficiency; - use of any medication including proton pump inhibitors (PPI) , oral anticoagulants and/or oral antibiotics in the past three months, plasma aspartate aminotransferase (ASAT and alanine aminotransferase (ALAT) are 2.5 times or more the upper limit of the normal range - Other causes of liver diseases besides NAFLD/NASH (e.g. hemachromatosis, auto-immune hepatitis, hepatitis B or C, alcoholic steatohepatitis) donors: use of medication ,fecal bacterial and viral pathogens including C.difficile,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| -changes in (small) intestinal microbiota and bacterial translocation after fecal transplantation - changes in MRI based liver and vascular wall imaging after fecal transplantation - changes in plasma (monocyte) and subcutaneous adipose tissue inflammatory markers after fecal transplantation | — |
Contacts
Public ContactM. Nieuwdorp
AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2
Outcome results
None listed