Tests a synbiotic supplement in adults with fatty liver disease
Tests a synbiotic supplement against placebo in adults with fatty liver disease.
Plain-language title generated from the registry record
Registry title: Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
Key facts
- Where
- Semarang, IndonesiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 25-55 with metabolic dysfunction-associated fatty liver disease (MAFLD), confirmed by a FibroScan test. It studies a synbiotic supplement versus placebo.
- Age
- 25 to 55 years
- Sex
- All sexes
- Disease stage
- MAFLD diagnosed by FibroScan, read by a liver and gut specialist, with a CAP score of 263 dB/m or higher
- Earlier treatment
- No antibiotics or probiotic, prebiotic or synbiotic use in the past 1 month. No use of vitamin E or omega-3 fatty acids.
- Biomarker or test result
- FibroScan CAP score of 263 dB/m or higher
Main reasons for not taking part
- Hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease or cirrhosis
- Pregnant, breastfeeding, or planning pregnancy during the study
- Alcohol intake of more than 40 g/day
- Decompensated liver disease (ascites, encephalopathy, variceal bleeding) or liver cancer (HCC)
- Past bowel resection or bariatric surgery, or chronic inflammatory bowel disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 55 years old?
Source: NCT06585982, who can take part
Where in Indonesia
- RSUP Dr. KariadiSemarang, IndonesiaContact: Hery D Purnomo, DrTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Universitas Diponegoro
- Trial code
- NCT06585982
- Record updated
- 12 November 2024
- Original description
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).Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: Patients with hepatitis (hepatitis B, hepatitis C, and autoimmune hepatitis) and alcoholic liver disease, cirrhosis of the liver; Patients with a history of alcohol consumption >40 g/day; Patients with a history of decompensated disease including ascites, encephalopathy, variceal haemorrhage; Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD); Patients with a history of antibiotic use or probiotic/prebiotic/synbiotic consumption in the past 1 month; Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness; Patients who are pregnant, or breastfeeding or in a programme to become pregnant during participation in this study; Patients with Hepatocellular Carcinoma (HCC); Use of Vitamin E and omega-3 fatty acids.