NCT06585982

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Universitas Diponegoro · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Non-alcoholic Fatty Liver Disease (NAFLD) is a common chronic liver disease estimated to affect 25% of the global population. NAFLD is defined as the presence of fat in the liver that is not associated with alcohol consumption. The researchers proposed a new term, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which covers a range of liver conditions associated with metabolic dysregulation, including obesity and type 2 diabetes. MAFLD is a systemic disease with complications such as obesity, which is closely related to glucose and lipid metabolism. Obesity is associated with comorbidities such as dyslipidaemia, hypertension and diabetes. The pathogenesis mechanism of MAFLD is complex and involves several factors such as mitochondrial dysfunction, oxidative stress, and increased free fatty acids (FFA). The 'multi-hit' theory explains how lifestyle, environmental and genetic factors contribute to the development of MAFLD. The gut microbiota also plays an important role in the development of MAFLD through the gut-liver axis, where microbiota imbalance can lead to inflammation and liver damage. Research shows the microbiota composition in MAFLD patients is different from healthy people, with an increase in Proteobacteria and Actinobacteria and a decrease in butyrate-producing bacteria. Interventions with probiotics and prebiotics (synbiotics) have been shown to reduce liver fibrosis and improve metabolic profiles. The investigators are interested in assessing the effects of synbiotics on changes in metabolic biomarkers, insulin, TNF-α, and gut microbiota in MAFLD patients.

Conditions

• Fatty Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Treatment	RILLUS is a synbiotic produced by Kalbe Farma
DIETARY_SUPPLEMENT	Control	Placebo produced by Kalbe Farma

Timeline

• Start date: 2024-03-04
• Primary completion: 2025-03-07
• Completion: 2025-03-07
• First posted: 2024-09-19
• Last updated: 2024-11-12

Locations

1 site across 1 country: Indonesia