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Synbiotics Impact on Insulin and TNF-ฮฑ in MAFLD: a Gut Microbiota Profile Analysis

RecruitingNAAges 25 Years - 55 YearsAllUniversitas Diponegoro
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In plain words

What the trial is, and whether it could suit you

Primary Objective: To analyze the effect of synbiotic supplementation on metabolic profile, insulin and TNF-ฮฑ 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-ฮฑ 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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ263 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.
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What it tests

  • Treatment
  • Control
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Where

1 site
RSUP Dr. Kariadi
Semarang, Indonesia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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