Observational Clinical Study on the Association Between Lactate-mediated Gut Microbiota Alterations and Disease Progression in Liver Cirrhosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational study, no intervention.
- Who it may be relevant to
- Registry conditions: Cirrhosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other observational study, no intervention
observational study, no intervention
Primary outcome measures
- Gut microbiota composition [Time frame: baseline]
- Lactate level [Time frame: baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhujiang Hospital of Southern Medical University — Guangzhou
Identifiers
NCT: NCT07455175 · Zhujiang-xuyi-cirrhosis