An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines With Metabolic Dysfunction-associated Fatty Liver Disease
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mengyao Hu
- Phone Number: +86 15870898392
- Email: 1377549166@qq.com
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510000
- Zhujiang Hospital of Southern Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy control
|
observational study, no intervention
|
|
MAFLD
|
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
Sponsor
Investigators
- Study Director: Xiaolong He, Southern Medical University, China
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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