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New treatment option for Fatty Liver Disease
Official title Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
ClinicalTrials.gov ID: NCT06585982
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 55
You may be able to join if
- 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
You likely can't join if
- 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
- Patients with Hepatocellular Carcinoma (HCC)
- Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD)
See the full eligibility criteria
- 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
- 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
- Patients with Hepatocellular Carcinoma (HCC)
- 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
- Use of Vitamin E and omega-3 fatty acids
- Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness.
The study team makes the final eligibility decision.
Where it's taking place
- Semarang, Semarang, Indonesia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Semarang, Semarang, Indonesia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.