Status:
NOT_YET_RECRUITING
Liver Steatosis in Pediatric CD Patients
Lead Sponsor:
University of Palermo
Collaborating Sponsors:
ARNAS Civico Di Cristina Benfratelli Hospital
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Conditions:
Celiac Disease in Children
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
1-14 years
Brief Summary
Celiac disease (CD) is an autoimmune enteropathy triggered by the intake of gluten, characterized by a genetic predisposition. Although, CD is often associated with malabsorption symptoms, a growing n...
Detailed Description
Background Celiac disease (CD), an autoimmune enteropathy triggered by the intake of gluten, is a widespread pathology, with a worldwide estimated prevalence of approximately 1%, characterized by both...
Eligibility Criteria
Inclusion
- Age \>1 and \<14 years
- Celiac Disease diagnosis according European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria
Exclusion
- age \<1 and \>14 years;
- self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;
- bacterial and/or parasitic infections;
- diagnosis of chronic inflammatory intestinal diseases and other organic pathologies affecting the digestive system (for example, serious liver diseases), nervous system diseases, immunological deficits and impairments that limit physical activity;
- diagnosis of cancer
- patients undergoing chemotherapy and/or radiotherapy.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06206616
Start Date
November 1 2025
End Date
September 30 2028
Last Update
March 28 2025
Active Locations (2)
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1
Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina"
Palermo, Palermo, Italy, 90127
2
General Pediatrics Unit, Children's Hospital "G. Di Cristina"
Palermo, Palermo, Italy, 90127