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…
ID
Bron
Verkorte titel
Aandoening
NAFLD/NASH;
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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
Doel van het onderzoek
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
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
multiple lean (preferably vegetarian/vegan) donor fecal transplantations
Algemeen / deelnemers
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Wetenschappers
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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,
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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,
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4189 |
| NTR-old | NTR4339 |
| Ander register | : MEC 13/207 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |