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Liver Steatosis in Pediatric CD Patients

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 1, 2025 to Nov 1, 2027
    • Site details revised at 2 of 2 sites
    v6
  2. Notable Primary completion date: Dec 31, 2026 to Dec 31, 2027
    • Start date: Jan 1, 2025 to Nov 1, 2025
    • Study completion date: Sep 30, 2027 to Sep 30, 2028
    v5
  3. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Start date: Jun 1, 2024 to Jan 1, 2025
    • Study completion date: Sep 30, 2026 to Sep 30, 2027
    • Site details revised at 2 of 2 sites
    v4
  4. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Start date: Feb 1, 2024 to Jun 1, 2024
    • Study completion date: Sep 30, 2025 to Sep 30, 2026
    v3
  5. Minor Study description shortened, about 259 wordsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06206616
Lead Sponsor University of Palermo
Collaborators: ARNAS Civico Di Cristina Benfratelli Hospital, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Conditions
(from sponsor)
Celiac Disease in Children, Non-Alcoholic Fatty Liver Disease
Related terms Celiac Disease, Non-alcoholic Fatty Liver Disease
Enrollment 91 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov