Actively Recruiting

Phase Not Applicable
Age: 25Years - 55Years
All Genders
ID06585982

Gut Microbiota Profile Analysis and Randomized Controlled Trial of Synbiotic Effects on Insulin and TNF-alpha in Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)

Led by Universitas Diponegoro · Updated on 2024-11-12

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

Universitas Diponegoro

Lead Sponsor

D

Dr. Kariadi General Hospital Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of synbiotic supplementation on patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD), a type of fatty liver condition linked to metabolic issues like obesity and diabetes. This research aims to see if synbiotics can change metabolic profiles, insulin levels, inflammatory marker TNF-alpha, and gut microbiota in these patients. The study is designed as a randomized controlled trial to analyze these effects in adults aged 25 to 55 years. Participants are divided into two groups: one receives RILLUS, a synbiotic supplement containing specific probiotic bacteria and prebiotic fibers, while the other receives a placebo that looks similar but lacks the live bacteria. Both groups will take two tablets daily for 12 weeks. Hospital visits for control and follow-up occur every 28 days over about four months. Participants will also keep logs to track supplement intake and food consumption. Throughout the study, participants will undergo various assessments including blood tests for hematology, metabolic profiles, insulin, TNF-alpha, and C-reactive protein at three months. Gut microbiota diversity will be evaluated at four months. The researchers will monitor compliance and collect data to understand how synbiotic treatment may influence these health markers. The total study duration for each participant is about four months, including supplementation and follow-up periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 25Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 25 to 55 years
  • Willing to provide informed consent to participate
  • Able and willing to take oral supplements as directed
  • Agrees to record supplement intake in a provided diary
  • Diagnosed with MAFLD by FibroScan with a CAP score of 263 dB/m or higher interpreted by a specialist
Not Eligible

You will not qualify if you...

  • Patients with hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, or liver cirrhosis
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • History of alcohol consumption exceeding 40 grams per day
  • History of decompensated liver disease such as ascites, encephalopathy, or variceal bleeding
  • Presence of hepatocellular carcinoma (liver cancer)
  • History of bowel resection or bariatric surgery
  • Chronic inflammatory bowel disease
  • Use of antibiotics or probiotic/prebiotic/synbiotic supplements in the past month
  • Use of Vitamin E or omega-3 fatty acids
  • Not hospitalized in the past month and no food restrictions related to illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants take synbiotic or placebo supplements daily to assess effects on insulin, TNF-alpha, and gut microbiota related to MAFLD.

Visits approximately at baseline and monthly during treatment

Follow-up

Duration - 1 month

Participants undergo assessments of gut microbiota diversity and metabolic profiles to monitor longer-term effects after treatment.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

RSUP Dr. Kariadi

Semarang, Semarang, Indonesia, 50244

Actively Recruiting

Loading map...

Research Team

H

Hery D Purnomo, Dr

A

Adiyan Pramono, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Randomized, Double-blind, Placebo-controlled, Single Ascen...

Fatty Liver Disease

Actively Recruiting

1 location

Assessment of FibroScan in Diagnosing MASLD Among the Chines...

Fatty Liver Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Machine learning improves the prediction of significant fibrosis in Asian patients with metabolic dysfunction-associated steatotic liver disease - The Gut and Obesity in Asia (GO-ASIA) Study.

Nipun Verma, Ajay Duseja, Manu Mehta...

https://pubmed.ncbi.nlm.nih.gov/38303507

The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases.

Naga Chalasani, Zobair Younossi, Joel E Lavine...

https://pubmed.ncbi.nlm.nih.gov/28714183

A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement.

Mohammed Eslam, Philip N Newsome, Shiv K Sarin...

https://pubmed.ncbi.nlm.nih.gov/32278004