Obesity Clinical Trial
Official title:
Effect of Dietary Intervention on Intestinal Microbiota in Patients With Non-alcoholic Fatty Liver Disease
Verified date | October 2017 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In patients with NAFLD/NASH, changes in liver lipid composition and function tests following a short dietary intervention are associated with changes in gut microbiota
Status | Completed |
Enrollment | 20 |
Est. completion date | September 15, 2016 |
Est. primary completion date | August 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: Obesity defined as BMI>30 Abnormal liver function tests defined as ALT > 1.5 times the upper limit of normal NAFLD present at liver biopsy Age > 18 years, < 60 years Exclusion Criteria: Inability or unwillingness to give consent Bulimia Other known cause of chronic liver disease, including hepatitis B or C, iron overload, Use of substances known to alter intestinal permeability, including alcohol and NSAIDs |
Country | Name | City | State |
---|---|---|---|
Switzerland | Geneva University Hospital | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | abundance of fecal abundance of fecal Bacteroidetes | Bacterial cells/g caecal content | thrice, at inclusion, day 21 and day 42 | |
Secondary | liver fat content | picsel/uni MRI | twice, at inclusion and day 21 | |
Secondary | liver function tests | mmol/l | four times, at screening, inclusion, day 21 and day 42 | |
Secondary | CRP | mg/l | thrice, at screening, inclusion and day 21 | |
Secondary | serum cytokines | ng/ml | twice, at inclusion and day 21 | |
Secondary | serum LPS | pg/ml | twice, at inclusion and day 21 | |
Secondary | Breath test pullulation | twice, at inclusion and day 21 | ||
Secondary | intestinal permeability | Polyethylene glycol 3350/Polyethylene glycol 400 ratio | twice, at inclusion and day 21 | |
Secondary | body composition | body composition in kg and % of body weight | thrice, at inclusion, day 21 and day 42 | |
Secondary | liver lipid composition (biopsy) | once, at screening |
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