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

NCT06585982 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

  • Fatty Liver Disease

Interventions

DIETARY_SUPPLEMENT

Treatment

RILLUS is a synbiotic produced by Kalbe Farma

DIETARY_SUPPLEMENT

Control

Placebo produced by Kalbe Farma

Sponsors & Collaborators

  • Dr. Kariadi General Hospital Medical Center

    collaborator OTHER

  • PT Kalbe Farma Tbk

    collaborator INDUSTRY

  • Universitas Diponegoro

    lead OTHER

Principal Investigators

  • Hery D Purnomo, Dr · Dr. Kariadi Medical Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2025-03-07
Completion
2025-03-07

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06585982 on ClinicalTrials.gov