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Liver Steatosis in Pediatric CD Patients

NCT06206616 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • ARNAS Civico Di Cristina Benfratelli Hospital

    collaborator OTHER

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

    collaborator OTHER

  • University of Palermo

    lead OTHER

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-11-01
Primary Completion
2027-12-31
Completion
2028-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206616 on ClinicalTrials.gov