Actively Recruiting
Liver Steatosis in Pediatric CD Patients
Led by University of Palermo · Updated on 2026-05-01
91
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
Sponsors
U
University of Palermo
Lead Sponsor
A
ARNAS Civico Di Cristina Benfratelli Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Liver Steatosis in Pediatric CD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 1 year and less than 14 years
- Diagnosed with Celiac Disease according to ESPGHAN criteria
You will not qualify if you...
- Age less than 1 year or greater than 14 years
- Self-exclusion of gluten/wheat from the diet and refusal to reintroduce it before study entry
- Current bacterial or parasitic infections
- Diagnosis of chronic inflammatory intestinal diseases or other serious digestive system diseases, nervous system diseases, immune deficiencies, or impairments limiting physical activity
- Diagnosis of cancer
- Undergoing chemotherapy or radiotherapy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina"
Palermo, Palermo, Italy, 90127
Actively Recruiting
2
General Pediatrics Unit, Children's Hospital "G. Di Cristina"
Palermo, Palermo, Italy, 90127
Actively Recruiting
Research Team
A
Aurelio Seidita, MD
CONTACT
A
Antonio Carroccio, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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