NCT07455149

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Apr 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Oct 2030

First Submitted

Initial submission to the registry

March 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

March 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

  • Abundance of Ruminococcus gnavus

    baseline

  • Biogenic amine levels

    baseline

Study Arms (2)

MAFLD

Other: observational study, no intervention

Healthy control

Other: observational study, no intervention

Interventions

observational study, no interventionOTHER

observational study, no intervention

Healthy controlMAFLD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Meet eligibility criteria

You may qualify if:

  • Willingness to participate in this study and to sign the informed consent form.
  • Age \>18 years.

You may not qualify if:

  • \. History of severe organic diseases in the liver, gastrointestinal tract, kidneys, or other systems, malignant tumors, or autoimmune diseases.
  • \. Patients who have had an acute infection or inflammatory disease within the past month.
  • \. Use of laxatives, antibiotics, probiotics, prebiotics, proton pump inhibitors, or other medications that may affect the gut microbiota within the past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Xiaolong He

    Southern Medical University, China

    STUDY DIRECTOR

Central Study Contacts

Mengyao Hu

CONTACT

+86 158708983921377549166@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

March 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)