Liver Steatosis in Pediatric CD Patients

Recruiting now

Conditions studied: Celiac Disease in Children, Non-Alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID: NCT06206616
Run by: University of Palermo
People needed: 91
Starts: 2027-11-01
Expected to finish: 2028-09-30
Last updated by the study team: 2026-05-01

Who can join

Age: 1 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age >1 and <14 years
Celiac Disease diagnosis according European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria

You may not qualify if…

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.

Where it is running

Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina" — Palermo, Palermo, Italy (enrolling)
General Pediatrics Unit, Children's Hospital "G. Di Cristina" — Palermo, Palermo, Italy (enrolling)

Full record on ClinicalTrials.gov

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