Clinical Trial

Liver Steatosis in Pediatric CD Patients

Recruiting
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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 number of affected subjects are overweight or frankly obese. One of the conditions that is most frequently detected in pauci/asymptomatic subjects is an increase in transaminases, which often regresses completely after the start of GFD. More recently, a specific liver disorder has shown a certain relevance in adult patients suffering from CD, so much so that the European Society for the Study of Coeliac Disease (ESsCD) has cited it among the possible comorbidities which should be screened in CD subjects: Non-Alcoholic Fatty Liver Disease (NAFLD). In adults, a non-random association between CD and NAFLD has been demonstrated, showing a CD prevalence rate of 2-14% among patients with NAFLD. Few studies have focused on this same aspect in pediatric age, reporting contrasting data. Several factors have been advocated as putative responsible of association between CD and NAFLD: dietary imbalances, intestinal mucosa permeability impairment, alterations of the intestinal microbiota. The objectives of this study are: 1. define, retrospectively, the prevalence of NAFLD in a pediatric population affected by CD and study its possible association with GFD. 2. define the possible role of the intestinal permeability alteration and/or the intestinal mucosa damage and/or the proinflammatory status in the development of NAFLD in children affected by CD.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-01-04; most recent amendment 2026-04-27.
Status change: Not Yet Recruiting → Recruiting 2026-04-27
Trial Details
NCT Number NCT06206616
Lead Sponsor University of Palermo
Collaborators: ARNAS Civico Di Cristina Benfratelli Hospital, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Conditions Celiac Disease in Children, Non-Alcoholic Fatty Liver Disease
Enrollment 91 participants
Start Date 2027-11-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-01