An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines With Metabolic Dysfunction-associated Fatty Liver Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhujiang Hospital

About this trial

Investigating the association between intestinal Ruminococcus gnavus and its derived biogenic amines with metabolic dysfunction-associated fatty liver disease

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1.Healthy individuals without a history of liver disease or related underlying diseases; or patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the latest guideline, Guidelines for the Prevention and Treatment of Metabolic (Dysfunction-Associated/Non-Alcoholic) Fatty Liver Disease (2024 Edition), meeting the following criteria: (i) imaging-based diagnosis of fatty liver and/or liver biopsy showing ≥5% macrovesicular steatosis in hepatocytes; (ii) presence of at least one component of metabolic syndrome (MetS); and (iii) exclusion of other causes of fatty liver, including excessive alcohol consumption (weekly ethanol intake ≥210 g for men and ≥140 g for women), malnutrition, hepatolenticular degeneration (Wilson's disease), and other potential etiologies.

Disqualifiers

1. History of severe organic diseases in the liver, gastrointestinal tract, kidneys, or other systems, malignant tumors, or autoimmune diseases.

Trial population

Meet eligibility criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • observational study, no intervention

    Other intervention

    observational study, no intervention

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: MAFLD1 intervention
Group B: Healthy control1 intervention

Trial outcomes

Primary outcomes

1

Abundance of Ruminococcus gnavus

Time frame
baseline
2

Biogenic amine levels

Time frame
baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: