Observational Clinical Study on the Association Between L... | NCT07455175

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Oct 1, 2028Estimated

Completion Date

Oct 1, 2028Estimated

First Submitted Date

Mar 3, 2026

First Submission Date that Met QC Criteria

Mar 3, 2026

First Posted Date

Mar 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cirrhosis			Other: observational study, no intervention
Healthy control			Other: observational study, no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational study, no intervention	Other	observational study, no intervention	Cirrhosis Healthy control

Measure	Description	Time Frame
Gut microbiota composition		baseline
Lactate level		baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- 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.

2. Willing to participate in this study and able to provide written informed consent.

Exclusion Criteria:

1. A history of severe organic diseases involving the liver, gastrointestinal tract, kidneys, or other organ systems; malignant tumors; or autoimmune diseases.

2. Patients with acute infection or inflammatory diseases within the past 1 month.

3. Pregnant or breastfeeding women.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Meet eligibility criteria

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Xu	Contact	+86 13364060425		xuyi2410@hotmail.com

Overall Officials

Name	Affiliation	Role
Xiaolong He	Southern Medical University, China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhujiang Hospital of Southern Medical University		Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D008722	Methods
D008919	Investigative Techniques