Impact of synbiotics on liver health and metabolism in fatty liver disease
Gut Microbiota Profile Analysis and Randomized Controlled Trials (RCT) Study of the Effect of Synbiotics on Insulin and TNF-α in Metabolic Dysfunction -Associated Fatty Liver Disease (MAFLD)
This study is testing whether taking synbiotics can improve liver health and metabolism in people with fatty liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Sponsor | Universitas Diponegoro Academic / other |
| Locations | 1 site (Semarang, Semarang) |
| Trial ID | NCT06585982 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of synbiotic supplementation on metabolic profiles, insulin levels, TNF-α, and gut microbiota in patients diagnosed with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). Participants will be divided into a treatment group receiving synbiotics and a control group receiving a placebo for 12 weeks, with follow-up visits every 28 days. The study aims to understand how synbiotics can influence liver health and metabolic functions in individuals with MAFLD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-55 years diagnosed with MAFLD who are willing to comply with the study requirements.
Not a fit: Patients with liver diseases such as hepatitis or cirrhosis, or those with a history of significant alcohol consumption, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve liver health and metabolic outcomes in patients with fatty liver disease.
How similar studies have performed: Previous studies have shown promising results with synbiotics in improving liver health and metabolic profiles, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients aged 25-55 years 2. Patients are willing to become research respondents after filling out informed consent 3. Patients can and are willing to consume supplements orally within a predetermined time 4. Patients are willing to record compliance with taking supplements in a diary that has been provided 5. Patients diagnosed with MAFLD by FibroScan interpreted by a specialist in gastroenterology-hepatology with a CAP score ≥263 dB/m Exclusion Criteria: 1. Patients with hepatitis (hepatitis B, hepatitis C, and autoimmune hepatitis) and alcoholic liver disease, cirrhosis of the liver 2. Patients who are pregnant, or breastfeeding or in a programme to become pregnant during participation in this study. 3. Patients with a history of alcohol consumption \>40 g/day. 4. Patients with a history of decompensated disease including ascites, encephalopathy, variceal haemorrhage 5. Patients with Hepatocellular Carcinoma (HCC) 6. Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD) 7. Patients with a history of antibiotic use or probiotic/prebiotic/synbiotic consumption in the past 1 month 8. Use of Vitamin E and omega-3 fatty acids 9. Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness.
Where this trial is running
Semarang, Semarang
- RSUP Dr. Kariadi — Semarang, Semarang, Indonesia (Recruiting)
Study contacts
- Principal investigator: Hery D Purnomo, Dr — Dr. Kariadi Medical Hospital
- Study coordinator: Hery D Purnomo, Dr
- Email: herydjagat@yahoo.co.id
- Phone: +628122803136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.