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Completed
NCT06537882
Evaluate the Effect of Synbiotics on MAFLD
Conditions: Metabolic Dysfunction-Associated Fatty Liver Disease
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 54
Sponsor: GenieBiome Limited
Location: GenieBiome Limited Hong Kong
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 omega 3 are safe and effective at treating NAFLD patients. In this study, investigators aim to investigate if the enhanced synbiotic preparation of SLP07 is efficacious in liver function improvement in subjects with MAFLD.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT06537882). StuddyBuddy aggregates publicly available trial information.