NCT06585982Recruiting
Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
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)
Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 3 Sept 2024
- Start date
- 4 Mar 2024
- Primary completion date
- 7 Mar 2025
- Lead sponsor
- Universitas Diponegoro
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06585982
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 4 Mar 2024 to the primary completion date, 7 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 25 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RSUP Dr. Kariadi Coordinator of this site? Confirm its status | Semarang | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.