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
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
Treatments tested in this trial
- Treatment
- Control
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universitas Diponegoro
Lead sponsor
Dr. Kariadi General Hospital Medical Center
Collaborator
PT Kalbe Farma Tbk
Collaborator
Source ClinicalTrials.gov