Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
A Single-arm, Open-label Clinical Study to Evaluate the Effect of SIM01 in Female Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Verified date | February 2024 |
Source | GenieBiome Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-alcoholic fatty liver disease is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota and improve liver function in females with non-alcoholic fatty liver disease. In this study, we aim to investigate if the synbiotics (prebiotics and probiotics) are efficacious subjects in liver function improvement in female subjects with Non-alcoholic fatty liver disease.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - Female subjects with NAFLD with CAP = 270 by fibroscan - Age = 55 - Subjects with or without diabetes or components of metabolic syndrome and having stable medication 3 months prior to enrolment - Written informed consent can be obtained Exclusion Criteria: - Known history of any secondary causes of NAFLD including alcoholic liver disease, drug-induced liver injury, autoimmune hepatitis, viral hepatitis, cholestatic liver disease and metabolic/genetic liver disease - 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 of a wine glass) - Consumption of systemic corticosteroids or methotrexate in the last 6 months - Concomitant probiotics or prebiotics one month prior to enrolment - Any condition or allergy history for probiotics - Subjects who are using antibiotics, insulin and Glucagon-like peptide-1(GLP1) such as dulaglutide, semaglutide - Malignancy |
Country | Name | City | State |
---|---|---|---|
Hong Kong | GenieBiome Limited | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
GenieBiome Limited |
Hong Kong,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Controlled Attenuation Parameter (CAP) score by fibroscan after taking SIM01 for 3 months | The change of CAP score measured by fibroscan. CAP score is a measurement of fat accumulation in the liver to further determine the steatosis grade. The CAP score ranges from 100 to 400 decibels per meter (dB/m). The higher the score, the more the steatosis is. | 3 months | |
Secondary | Change in liver enzymes (alanine aminotransferase (ALT) and aspartate transaminase (AST)) across the study period. | The change in the level of liver enzymes. | 3 months | |
Secondary | Change in fasting lipid and HbA1c across the study period. | The change in the level of lipid profiles | 3 months | |
Secondary | Change of body mass index (BMI) across the study period. | The change of body weight and body height | 3 months | |
Secondary | Change of body waist circumference across the study period. | The change of waist circumference | 3 months | |
Secondary | Change in interleukin-6 (IL-6) across the study period. | The change in the one of the immunity marker | 3 months |
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