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Search / Trial NCT06623084

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

Launched by STEFANIA BASILI · Oct 1, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Platelets Liver Metabolomics Microbiota

ClinConnect Summary

The iGAL-AXIS clinical trial is investigating how certain blood cells called platelets, which can be affected by substances from the gut, influence the progression of liver diseases like Non-alcoholic Fatty Liver Disease (NAFLD) and its more serious forms, including NASH (Nonalcoholic Steatohepatitis) and cirrhosis. The researchers believe that the interaction between these platelets and the liver could lead to increased inflammation and worsen liver conditions. The study has two main goals: to find specific features of platelets that relate to how liver disease progresses and to better understand how changes in gut health might affect this process.

To participate in this trial, individuals must be over 18 years old and diagnosed with NAFLD according to established guidelines. However, those with more severe liver issues, certain gastrointestinal conditions, or who have recently taken specific medications will not be eligible. While the trial is not yet recruiting participants, those who join can expect to contribute valuable information that may help improve understanding and treatment of chronic liver diseases in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • age\>18;
  • NAFLD patients according to EASL Guidelines 2016.
  • Exclusion Criteria:
  • decompensated cirrhosis, other causes of chronic liver disease (infectious and immune-mediated); malabsorption syndromes (i.e., celiac disease, food allergy, small bowel bacterial overgrowth);
  • inflammatory bowel disease; previous GI surgery;
  • immunodeficiencies; neurological handicaps;
  • use of NSAIDs, antibiotics, probiotics, or anti-secretory drugs within the 2 months preceding enrollment;
  • abnormality of hemostasis and thrombosis; malignancies.

About Stefania Basili

Stefania Basili is a dedicated clinical trial sponsor committed to advancing medical research through innovative and rigorous study designs. With a focus on enhancing patient outcomes, Stefania Basili collaborates with leading healthcare professionals and institutions to facilitate the development of new therapies and treatments. The organization prioritizes ethical standards and regulatory compliance, ensuring the safety and well-being of participants throughout the trial process. By fostering partnerships and leveraging cutting-edge methodologies, Stefania Basili aims to contribute significantly to the scientific community and improve healthcare solutions globally.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported