No registrations found.
ID
Source
Brief title
Health condition
NAFLD/NASH;
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
-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
Background summary
with this study we would like to investigate whether (small) intestinal microbiota are causally involved in NASH and chronic low grade inflammation in obese humans via multiple fecal transplantations using either lean (preferably vegan/vegetarian) fecal donors (allogenic) or own (autologous) feces
Study objective
we would like to investigate whether multiple fecal transplantations using either allogenic (lean preferably vegetarian/vegan donor) or autologous (own) donors have a beneficial effect on non alcoholic steatohepatitis (NASH) using biopsy and MRI images and which intestinal microbiota are involved
Study design
liver/ fat biopsy and MRI imaging at 0 and 6 months
intestinal microbiota analyses and plasma inflammatory markers at baseline, 8,16 and 24 weeks
Intervention
multiple lean (preferably vegetarian/vegan) donor fecal transplantations
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4189 |
| NTR-old | NTR4339 |
| Other | : MEC 13/207 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |