Status:
UNKNOWN
Intestinal Microbiota and NAFLD Pre and Post Bariatric Surgery
Lead Sponsor:
Johane Allard
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Morbid Obesity
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) includes benign hepatic simple steatosis (SS) and steatohepatitis (NASH), which is characterised by inflammation leading to fibrosis and cirrhosis. NAFLD is t...
Detailed Description
Study Design: A. Cross-sectional study: Sixty patients with morbid obesity undergoing bariatric surgery diagnosed with NAFLD on liver biopsy (30 SS, 30 NASH). Main hypothesis: The ratio of Firmicutes/...
Eligibility Criteria
Inclusion
- BMI\>40 kg/m2 or BMI\>35-40 kg/m2 with severe weight loss comorbidities
- Male or female, equal or over 18 years of age
- Alcohol consumption is leass than 20 g/d
Exclusion
- No diagnosis of NAFLD
- Having liver disease of other etiology
- Having advance liver disease
- Having abnormal coagulation or other reason contraindicating a Liver Biopsy
- On medication known to precipitate steatohepatitis 6 months prior to entry
- On regular intake of non-steroidal anti-inflammatory drugs, prebiotics, probiotics and antibiotics, ursodeoxycholic or any experimental drug in the 3 months prior to study entry
- Having type-1 diabetes, chronic gastrointestinal diseases, previous gastrointestinal surgery modifying the anatomy (prior to bariatric surgery)
- Smoking
- Pregnancy or Breastfeeding
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01856465
Start Date
June 1 2013
End Date
August 30 2023
Last Update
November 2 2022
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4