Evaluate the Effect of Synbiotics on MAFLD (NCT06537882) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluate the Effect of Synbiotics on MAFLD
Hong Kong54 participantsStarted 2024-05-17
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with a reduction of at least 1 grade of steatosis AND/OR >10% reduction in CAP scores at 3 months