An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines With Metabolic Dysfunction-associated Fatty Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational study, no intervention.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction-associated Fatty Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Investigating the association between intestinal Ruminococcus gnavus and its derived biogenic amines with metabolic dysfunction-associated fatty liver disease
Interventions
- Other observational study, no intervention
observational study, no intervention
Primary outcome measures
- Abundance of Ruminococcus gnavus [Time frame: baseline]
- Biogenic amine levels [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- 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.
2.Willingness to participate in this study and to sign the informed consent form.
3.Age >18 years.
Exclusion criteria
- 1\. History of severe organic diseases in the liver, gastrointestinal tract, kidneys, or other systems, malignant tumors, or autoimmune diseases.
2\. Patients who have had an acute infection or inflammatory disease within the past month.
3\. Use of laxatives, antibiotics, probiotics, prebiotics, proton pump inhibitors, or other medications that may affect the gut microbiota within the past month.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhujiang Hospital of Southern Medical University — Guangzhou
Identifiers
NCT: NCT07455149 · Zhujianghmy-MAFLD