Health TrialsbyHealthPanel

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

ConditionFatty Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-55
SponsorUniversitas Diponegoro

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment

    Dietary supplement

    RILLUS is a synbiotic produced by Kalbe Farma

  • Control

    Dietary supplement

    Placebo produced by Kalbe Farma

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: RILLUSActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete Hematology

Complete Hematology analysis before and after intervention

Time frame
3 months
2

Metabolic Profile

Analyzing fasting glucose and HbA1C before and after the intervention

Time frame
3 months
3

Metabolic Profile

Analyzing liver function SGOT (Serum Glutamic Oxaloacetic Transaminase) and SGPT (Serum Glutamic Pyruvic Transaminase) before and after intervention

Time frame
3 months
4

Metabolic Profile

Analyzing lipid profile (total cholesterol, triglycerides, HDL, LDL) before and after intervention

Time frame
3 months

Secondary outcomes

1

Alpha Diversity of Gut Microbioata

Calculation of Gut Microbiota's species diversity index using Shannon Index, where the gene expresion were observed at OTUs level.

Time frame
4 months
2

Anti-HCV

Anti-HCV test is used as a screening to ensure respondents do not have hepatitis

Time frame
3 months
3

HBsAg (Hepatitis B Surface Antigen)

HBsAg test is used as a screening to ensure respondents do not have hepatitis

Time frame
3 months
4

Beta Diversity of Gut Microbioata

Calculation of Gut Microbiota's species diversity index using Bray Curtis, where the gene expresion were observed at OTUs level.

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitas Diponegoro

Lead sponsor

Dr. Kariadi General Hospital Medical Center

Collaborator

PT Kalbe Farma Tbk

Collaborator

Source ClinicalTrials.gov
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