Status:
UNKNOWN
The Effect of Consecutive Fecal Microbiota Transplantation on Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Dutch Donor Feces Bank
Vedanta Biosciences
Conditions:
NAFLD
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Nonalcoholic fatty liver disease (NAFLD) is a disease of alarmingly increasing prevalence, linked to metabolic, cardiovascular and malignant morbidity and without any officially approved treatment. It...
Detailed Description
Nonalcoholic fatty liver disease (NAFLD) is a disease of alarmingly increasing prevalence, linked to metabolic, cardiovascular and malignant morbidity and without any officially approved treatment. It...
Eligibility Criteria
Inclusion
- 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
- 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
- use of GLP-1 RA or SU-derivatives
- 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
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04465032
Start Date
December 10 2019
End Date
December 31 2021
Last Update
July 9 2020
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA