Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
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)
Universitas Diponegoro
50 participants
Mar 4, 2024
INTERVENTIONAL
Conditions
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 Disease (MAFLD). Research question: Are there any changes in metabolic profile, Insulin and TNF-α and gut microbiota changes in MAFLD patients after synbiotic supplementation Participants will: * Treatment group given supplementation and the control group will be given placebo at a dose of 2x1 tablet for 12 weeks. * Patients will visit the hospital every 28 days for up to 4 months for control and follow-up supplementation. * patients will be given a supplement consumption compliance logbook and a food record logbook used to record food consumption filled in by the patient.
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
RILLUS is a synbiotic produced by Kalbe Farma
Placebo produced by Kalbe Farma
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06585982