Liver Steatosis in Pediatric CD Patients

Sponsor
University of Palermo
Study ID
NCT06206616
Status
Recruiting
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Conditions

  • Celiac Disease in Children
  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
1 Year - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • Gluten-free diet — BEHAVIORAL
    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.

Study Details

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 Dates

First listed
Jan 16, 2024
Start date
Nov 1, 2027
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
91 participants (estimated)

Arms

  • Arm: Celiac Disease Children
    Pediatric patients affected by newly diagnosed CD according to the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria will be evaluated before the start of gluten-free diet and after 6 months of gluten-free diet.

Primary Outcome Measure

Historical Nonalcoholic Fatty Liver Disease Prevalence in Pediatric Celiac Disease Patients before Gluten Free Diet [ Time Frame: Retrospective (years 2000-2023) ]

Central Contacts

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