Status:
RECRUITING
Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
Lead Sponsor:
Universitas Diponegoro
Collaborating Sponsors:
Dr. Kariadi General Hospital Medical Center
PT Kalbe Farma Tbk
Conditions:
Fatty Liver Disease
Eligibility:
All Genders
25-55 years
Phase:
NA
Brief Summary
Primary Objective: To analyze the effect of synbiotic supplementation on metabolic profile, insulin and TNF-α and gut microbiota changes in patients with Metabolic dysfunction-Associated Fatty Liver D...
Detailed Description
Non-alcoholic Fatty Liver Disease (NAFLD) is a common chronic liver disease estimated to affect 25% of the global population. NAFLD is defined as the presence of fat in the liver that is not associate...
Eligibility Criteria
Inclusion
- Adult patients aged 25-55 years
- Patients are willing to become research respondents after filling out informed consent
- Patients can and are willing to consume supplements orally within a predetermined time
- Patients are willing to record compliance with taking supplements in a diary that has been provided
- Patients diagnosed with MAFLD by FibroScan interpreted by a specialist in gastroenterology-hepatology with a CAP score ≥263 dB/m
Exclusion
- Patients with hepatitis (hepatitis B, hepatitis C, and autoimmune hepatitis) and alcoholic liver disease, cirrhosis of the liver
- Patients who are pregnant, or breastfeeding or in a programme to become pregnant during participation in this study.
- Patients with a history of alcohol consumption \>40 g/day.
- Patients with a history of decompensated disease including ascites, encephalopathy, variceal haemorrhage
- Patients with Hepatocellular Carcinoma (HCC)
- Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD)
- Patients with a history of antibiotic use or probiotic/prebiotic/synbiotic consumption in the past 1 month
- Use of Vitamin E and omega-3 fatty acids
- Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness.
Key Trial Info
Start Date :
March 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06585982
Start Date
March 4 2024
End Date
March 7 2025
Last Update
November 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
RSUP Dr. Kariadi
Semarang, Semarang, Indonesia, 50244