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NCT06206616

Liver Steatosis in Pediatric CD Patients

Sponsor: University of Palermo

View on ClinicalTrials.gov

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.

Official title: Liver Steatosis in Pediatric Celiac Disease Patients: Exploring the Epidemiological and Pathophysiological Features of an Underestimated Condition

Key Details

Gender

All

Age Range

1 Year - 14 Years

Study Type

OBSERVATIONAL

Enrollment

91

Start Date

2025-11-01

Completion Date

2028-09-30

Last Updated

2025-03-28

Healthy Volunteers

No

Interventions

BEHAVIORAL

Gluten-free diet

Pediatric patients affected by newly diagnosed Celiac Disease (CD) according to the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria will start a gluten-free diet (GFD), as normally expected for all CD patients. The assessment of adherence to the GFD will be carried out through the monthly compilation, by the children and/or their parents, of a specifically created and validated questionnaire. Before and after the start of GFD enrolled patients will undergo an abdominal ultrasound to establish the presence and degree of hepatic steatosis.

Locations (2)

Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina"

Palermo, Palermo, Italy

General Pediatrics Unit, Children's Hospital "G. Di Cristina"

Palermo, Palermo, Italy