search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effect of Multiple healthy donor intestinal microbiota infusions on non Alcoholic Steatosis Hepatis (NASH) and vascular function; the MASH trial


- candidate number15951
- NTR NumberNTR4339
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2013
- Secondary IDsMEC 13/207  
- Public TitleEffect of Multiple healthy donor intestinal microbiota infusions on non Alcoholic Steatosis Hepatis (NASH) and vascular function; the MASH trial
- Scientific TitleEffect of Multiple healthy donor intestinal microbiota infusions on non Alcoholic Steatosis Hepatis (NASH) and vascular function; the MASH trial
- ACRONYMMASH trial
- hypothesiswe 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
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaPatients: 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 criteriaPatients:
- 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,
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2017
- Target number of participants54
- Interventionsmultiple lean (preferably vegetarian/vegan) donor fecal transplantations
- Primary outcomeThe 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
- Timepointsliver/ fat biopsy and MRI imaging at 0 and 6 months
intestinal microbiota analyses and plasma inflammatory markers at baseline, 8,16 and 24 weeks
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
CVON
- PublicationsN/A
- Brief summarywith 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
- Main changes (audit trail)
- RECORD28-dec-2013 - 10-jan-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl