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Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis

RECRUITINGN/ASponsored by Universitas Diponegoro
Actively Recruiting
PhaseN/A
SponsorUniversitas Diponegoro
Started2024-03-04
Est. completion2025-03-07
Eligibility
Age25 Years – 55 Years
Healthy vol.Accepted

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

Age: 25 Years – 55 YearsHealthy volunteers accepted
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.

Conditions2

Fatty Liver DiseaseLiver Disease

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