NCT07455175

Brief Summary

To investigate the association between lactate-mediated alterations in the gut microbiota and disease progression in patients with liver cirrhosis; and to examine the correlations of lactate levels among serum, fecal, and tissue samples in patients with liver cirrhosis.

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
28mo left

Started Apr 2026

Typical duration 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

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Oct 2028

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
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

March 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (2)

  • Gut microbiota composition

    baseline

  • Lactate level

    baseline

Study Arms (2)

Cirrhosis

Other: observational study, no intervention

Healthy control

Other: observational study, no intervention

Interventions

observational study, no interventionOTHER

observational study, no intervention

CirrhosisHealthy control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Meet eligibility criteria

You may qualify if:

  • \- 1. Healthy individuals without a history of liver disease or related underlying disorders; or patients diagnosed with liver cirrhosis and its complications based on imaging and/or liver biopsy, with a history of chronic liver disease for more than 6 months. Etiologies include chronic hepatitis B virus infection, nonalcoholic fatty liver disease, and alcoholic liver disease, among others.
  • \. Willing to participate in this study and able to provide written informed consent.

You may not qualify if:

  • \. A history of severe organic diseases involving the liver, gastrointestinal tract, kidneys, or other organ systems; malignant tumors; or autoimmune diseases.
  • \. Patients with acute infection or inflammatory diseases within the past 1 month.
  • \. Pregnant or breastfeeding women.

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

Conditions

Fibrosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Xiaolong He

    Southern Medical University, China

    STUDY DIRECTOR

Central Study Contacts

Yi Xu

CONTACT

+86 13364060425xuyi2410@hotmail.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, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)