The effect of consecutive fecal microbiota transplantation on Non-Alcoholic Fatty Liver Disease (NAFLD) - a randomized-controlled trial

Completed

Conditions: hepatic fat accumulation
Non-Alcoholic Fatty Liver Disease (NAFLD)
10019654
10013317

Registration Number: NL-OMON48776

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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 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 (< 3 months) of antibiotics
- use of possible drugs interfering microbiota or recent (< 3 months) changes
in dosages
- Recent (< 3 months) weight change (>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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Prior to randomization, and at 12 weeks, patients will undergo LiverMultiscan<br /><br>to non-invasively quantify liver fat accumulation and other features of NAFLD.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are weight, waist, blood pressure, metabolic parameters<br /><br>(including glucose, cholesterol, pancreatic beta-cell function, HOMA-IR),<br /><br>liver enzymes, gut-microbiota, bile composition, objective and subjective<br /><br>stress. Stool samples will be collected for microbiota analysis at time point<br /><br>0, 3, 6 and 12 weeks. </p><br>