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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07455149

Enrollment

200

Registered

2026-03-06

Start date

2026-04-01

Completion date

2030-10-01

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease

Brief summary

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

Interventions

OTHERobservational study, no intervention

observational study, no intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Abundance of Ruminococcus gnavus	baseline
Biogenic amine levels	baseline

Countries

China

Contacts

CONTACTMengyao Hu

1377549166@qq.com+86 15870898392

STUDY_DIRECTORXiaolong He

Southern Medical University, China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026