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

March 3, 2026 updated by: Zhujiang Hospital
Investigating the association between intestinal Ruminococcus gnavus and its derived biogenic amines with metabolic dysfunction-associated fatty liver disease

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhujiang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Meet eligibility criteria

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy control
Other: observational study, no intervention
observational study, no intervention
MAFLD
Other: observational study, no intervention
observational study, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abundance of Ruminococcus gnavus
Time Frame: baseline
baseline
Biogenic amine levels
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Study Director: Xiaolong He, Southern Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhujianghmy-MAFLD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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