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)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

• Patients diagnosed with MAFLD by FibroScan interpreted by a specialist in gastroenterology-hepatology with a CAP score ≥263 dB/m

Locations
Other Locations
Indonesia
RSUP Dr. Kariadi
RECRUITING
Semarang
Contact Information
Primary
Hery D Purnomo, Dr
herydjagat@yahoo.co.id
+628122803136
Backup
Adiyan Pramono, PhD
adriyanpramono@fk.undip.ac.id
+6281282037051
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2025-03-07
Participants
Target number of participants: 50
Treatments
Active_comparator: RILLUS
Treatment group receive RILLUS, a synbiotic that each tablet contains Viable cells 1.0 x 109 CFU containing three types of prebiotic species (Lactobacillus plantarum 8.55mg, Streptococcus thermophilus 8.55mg, and Bifidobacterium bifidum 2.55 mg) and Fructooligosaccharide (FOS) 480 mg as prebiotic.
Placebo_comparator: Placebo
Control group receive what appeared to be RILLUS, but only placebo containing Fructooligosaccharide, Xylitol DC, Isomalt, Microcrystalline cellulose, Corn starch, Milk flavor powder, Hydroxypropyl methylcellulose, Vanilla flavor powder, Magnesium stearate
Related Therapeutic Areas
Sponsors
Collaborators: PT Kalbe Farma Tbk, Dr. Kariadi General Hospital Medical Center
Leads: Universitas Diponegoro

This content was sourced from clinicaltrials.gov

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