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RECRUITING
NCT06585982
NA

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

Sponsor: Universitas Diponegoro

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

25 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-03-04

Completion Date

2025-03-07

Last Updated

2024-11-12

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Treatment

RILLUS is a synbiotic produced by Kalbe Farma

DIETARY_SUPPLEMENT

Control

Placebo produced by Kalbe Farma

Locations (1)

RSUP Dr. Kariadi

Semarang, Semarang, Indonesia