hepatic fat accumulation Non-Alcoholic Fatty Liver Disease (NAFLD)
Conditions
Interventions
Patients will be randomized for infusion of allogenic (lean donor) or
autologous (own) feces through a nasoduodenal tube at time points 0, 3 and 6
weeks.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Obese (BMI > 27 kg/m2) - Males and postmenopausal females - Aged 18 to 70 years - Hepatic steatosis defined as increased hyperechogenicity of the liver on abdominal ultrasound and/or histological signs of steatosis - Written informed consent
Exclusion criteria
Exclusion criteria: - Exclusion criteria for MRI (claustrophobia, pacemaker, metal implants, etc) - Any other liver disease than NAFLD/NASH - Present excessive alcohol use defined as > 2 units/day - Recent use (5%) - Cardiovascular co-morbidity defined as heart failure, coronary insufficiency and hypertension in past history - Previous use of glucocorticosteroids, hormonal substitution, pagitaxel, theofyllin, amiodarone, myelosuppresive agents. - A psychiatric, addictive or any other disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prior to randomization, and at 12 weeks, patients will undergo LiverMultiscan to non-invasively quantify liver fat accumulation and other features of NAFLD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are weight, waist, blood pressure, metabolic parameters (including glucose, cholesterol, pancreatic beta-cell function, HOMA-IR), liver enzymes, gut-microbiota, bile composition, objective and subjective stress. Stool samples will be collected for microbiota analysis at time point 0, 3, 6 and 12 weeks. | — |
Countries
Netherlands
Outcome results
None listed