Gut Microbiota and Modulation of Liver Damage in NAFLD (NCT02158351) | Clinical Trial Compass
CompletedNot Applicable
Gut Microbiota and Modulation of Liver Damage in NAFLD
Italy44 participantsStarted 2013-11
Plain-language summary
Several experimental data suggest that gut-derived endotoxin and GM composition can act as a "second hit" or insult to convert hepatic SS to NASH and cause both local hepatic and systemic inflammation.This study's aim is to analyze microbiota diversity, providing information both on intestinal microbial composition and on the metabolic processes linked to them. In addition, we will correlate, for the first time, GM composition to hepatic and white adipose tissue gene expression patterns of interest and serum and fecal markers possibly related to impaired fat storage and inflammation. We aim to provide preliminary data to design future intervention studies with pre- or probiotics or bile acid derivatives to prevent/treat inflammation and fibrosis in NAFLD patients.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female, equal or over 18 years old
✓. Eligible for Sleeve Gastrectomy for obesity with BMI 35-50 kg/m2
✓. Eligible for Cholecystectomy for symptomatic gallstones and bright liver at ultrasounds
✓. Alcohol consumption is less than 20 g/d
Exclusion criteria
✕. Having liver disease of other etiology
✕. Having advanced liver disease
✕. Having abnormal coagulation or other reason contraindicating a Liver Biopsy
✕. On regular intake of medications known to cause or exacerbate steatohepatitis or antibiotic, pre- or probiotics in the previous 3 months
✕. Use of vitamin E or fish oil supplements in the previous 2 months