Integrated Phenotyping of the Gut-plAtelet-Liver AXIS in the Progression of Chronic Liver Disease (iGAL-AXIS)

StatusUnknown
PhaseNot specified
Started

Record status This record was last updated October 4, 2024 (before its estimated March 12, 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Objective of the study Our working hypothesis is that platelets activated by gut-derived metabolites dock in the liver of NAFLD patients and amplify the inflammatory state by releasing pro-inflammatory cytokines/chemokines, which in turn recruit and activate leukocytes in the liver sinusoids. Combined stimuli from leukocytes and platelets would then lead to metabolic reprogramming of hepatocytes, progression to NASH and eventually cirrhosis. To test this hypothesis, the investigators propose 2 objectives. Primary objective: To identify platelet features that correlate with liver disease progression. Secondary objective: To study the mechanistic relationship between gut dysbiosis, metabolome composition, inflammation, and platelet activation in chronic liver disease.
Trial Details
NCT Number NCT06623084
Lead Sponsor Stefania Basili
Collaborators: University of Rome Tor Vergata, Catholic University of the Sacred Heart
Conditions
(from sponsor)		 Non-alcoholic Fatty Liver Disease (NAFLD), NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Control Condition
Related terms Fibrosis, Non-alcoholic Fatty Liver Disease
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov