Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
Recruiting · NCT06585982 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitas Diponegoro
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- RSUP Dr. Kariadi - Semarang, Semarang, Indonesia