Status:
ACTIVE_NOT_RECRUITING
Evaluate the Effect of Synbiotics on MAFLD
Lead Sponsor:
GenieBiome Limited
Collaborating Sponsors:
Microbiota I-Centre (MagIC)
Conditions:
Metabolic Dysfunction-Associated Fatty Liver Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota, while Vitamin E and omeg...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide.(1) The prevalence of NAFLD is estimated to be about 20%-30% in the Western world (2) and increasin...
Eligibility Criteria
Inclusion
- Subjects with MAFLD with CAP ≥ 270 by fibroscan
- Age ≥ 50
- Subjects with diabetes or components of metabolic syndrome
- Subjects have been taking stable medication 3 months prior to enrolment and are expected to remain stable throughout the study period
- Written informed consent can be obtained
Exclusion
- Known history of any secondary causes of MAFLD including alcoholic liver disease, drug-induced liver injury, autoimmune hepatitis, viral hepatitis, cholestatic liver disease and metabolic/genetic liver disease
- Active malignancy (on any kind of treatments for the known cancer)
- Known diabetes with poor control (HbA1c \> 8.5%) within 3 months
- Significant alcohol consumption (over 10g per day: a half pint or half bottle of beer or a standard-size wine glass)
- Subjects who are using insulin and Glucagon-like peptide-1(GLP1) such as dulaglutide, semaglutide
- Consumption of systemic corticosteroids or methotrexate in the last 6 months
- Use of antibiotics, probiotics or prebiotics one month prior to enrolment
- Taking any supplements which are claimed to possibly protect the liver or improve liver functions including vitamin E and omega-3
- Any condition or allergy history for probiotics
- Any allergy to vitamin E, omega-3 or lactose
Key Trial Info
Start Date :
May 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06537882
Start Date
May 17 2024
End Date
June 30 2026
Last Update
April 3 2025
Active Locations (1)
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1
GenieBiome Limited
Hong Kong, Hong Kong