NCT05885373Completed
A Clinical Study to Evaluate the Effect of SIM01 in Female With NAFLD
A Single-arm, Open-label Clinical Study to Evaluate the Effect of SIM01 in Female Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Source: ClinicalTrials.gov · Last updated 22 Feb 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 14 Apr 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- GenieBiome Limited
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05885373
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Mar 2023 to the primary completion date, 31 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Consumption of systemic corticosteroids or methotrexate in the last 6 months
- Concomitant probiotics or prebiotics one month prior to enrolment
Other illness
- 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
- Any condition or allergy history for probiotics
- Malignancy
Lab values
- Known diabetes with poor control (HbA1c \> 8.5%) within 3 months
Other
- Significant alcohol consumption (over 10g per day: a half pint or half bottle of beer or a standard-size of a wine glass)
- Subjects who are using antibiotics, insulin and Glucagon-like peptide-1(GLP1) such as dulaglutide, semaglutide
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GenieBiome Limited Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.