NCT06585982 Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
| NCT ID | NCT06585982 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitas Diponegoro |
| Condition | Fatty Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-04 |
| Primary Completion | 2025-03-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-03-04 with a primary completion date of 2025-03-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Adult patients aged 25-55 years 2. Patients are willing to become research respondents after filling out informed consent 3. Patients can and are willing to consume supplements orally within a predetermined time 4. Patients are willing to record compliance with taking supplements in a diary that has been provided 5. Patients diagnosed with MAFLD by FibroScan interpreted by a specialist in gastroenterology-hepatology with a CAP score ≥263 dB/m Exclusion Criteria: 1. Patients with hepatitis (hepatitis B, hepatitis C, and autoimmune hepatitis) and alcoholic liver disease, cirrhosis of the liver 2. Patients who are pregnant, or breastfeeding or in a programme to become pregnant during participation in this study. 3. Patients with a history of alcohol consumption \>40 g/day. 4. Patients with a history of decompensated disease including ascites, encephalopathy, variceal haemorrhage 5. Patients with Hepatocellular Carcinoma (HCC) 6. Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD) 7. Patients with a history of antibiotic use or probiotic/prebiotic/synbiotic consumption in the past 1 month 8. Use of Vitamin E and omega-3 fatty acids 9. Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness.
Contact & Investigator
Hery D Purnomo, Dr
PRINCIPAL INVESTIGATOR
Dr. Kariadi Medical Hospital
Frequently Asked Questions
Who can join the NCT06585982 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 55 Years, studying Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06585982 currently recruiting?
Yes, NCT06585982 is actively recruiting participants. Contact the research team at herydjagat@yahoo.co.id for enrollment information.
Where is the NCT06585982 trial being conducted?
This trial is being conducted at Semarang, Indonesia.
Who is sponsoring the NCT06585982 clinical trial?
NCT06585982 is sponsored by Universitas Diponegoro. The principal investigator is Hery D Purnomo, Dr at Dr. Kariadi Medical Hospital. The trial plans to enroll 50 participants.