NCT06537882Completed
Evaluate the Effect of Synbiotics on MAFLD
A Double-blind Randomized Placebo-controlled Study to Evaluate the Effect of Synbiotics SLP07 on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD-RCT)
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 29 Jul 2024
- Start date
- 22 May 2024
- Primary completion date
- 7 Jan 2025
- Lead sponsor
- GenieBiome Limited
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06537882
What you commit to
- Study type: Interventional
- Participants enrolled: 54
- From 22 May 2024 to the primary completion date, 7 Jan 2025
- 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
- Use of antibiotics, probiotics or prebiotics one month prior to enrolment
Other illness
- 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)
- Any condition or allergy history for probiotics
- Any allergy to vitamin E, omega-3 or lactose
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 wine glass)
- Subjects who are using insulin and Glucagon-like peptide-1(GLP1) such as dulaglutide, semaglutide
- Taking any supplements which are claimed to possibly protect the liver or improve liver functions including vitamin E and omega-3
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · 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.