NCT06206616 Liver Steatosis in Pediatric CD Patients
| NCT ID | NCT06206616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Palermo |
| Condition | Celiac Disease in Children |
| Study Type | OBSERVATIONAL |
| Enrollment | 91 participants |
| Start Date | 2027-11-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 91 participants in total. It began in 2027-11-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age \>1 and \<14 years * Celiac Disease diagnosis according European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06206616 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 14 Years, studying Celiac Disease in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06206616 currently recruiting?
Yes, NCT06206616 is actively recruiting participants. Contact the research team at aurelio.seidita@unipa.it for enrollment information.
Where is the NCT06206616 trial being conducted?
This trial is being conducted at Palermo, Italy, Palermo, Italy.
Who is sponsoring the NCT06206616 clinical trial?
NCT06206616 is sponsored by University of Palermo. The trial plans to enroll 91 participants.