Clinical Trial

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

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Record status
This record was last updated November 12, 2024 (before its estimated March 7, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-03.
Trial Details
NCT Number NCT06585982
Lead Sponsor Universitas Diponegoro
Collaborators: Dr. Kariadi General Hospital Medical Center, PT Kalbe Farma Tbk
Conditions Fatty Liver Disease
Enrollment 50 participants
Start Date 2024-03-04
Primary Completion 2025-03-07 (estimated)
Study Completion 2025-03-07 (estimated)
Updated on ClinicalTrials.gov 2024-11-12