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NCT Number: NCT07455175

Observational Clinical Study on the Association Between Lactate-mediated Gut Microbiota Alterations and Disease Progression in Liver Cirrhosis.

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.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Patients with acute infection or inflammatory diseases within the past 1 month.
  • Pregnant or breastfeeding women.

Treatment and study plan

Observational study, no intervention

Other

observational study, no intervention

Primary outcomes

  1. Gut microbiota composition

    Time frame: baseline

  2. Lactate level

    Time frame: baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Xu

CONTACT

[email protected]

+86 13364060425

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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