Liver Steatosis in Pediatric CD Patients
Recruiting · NCT06206616 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Palermo
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
2 locations listed.
- Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina" - Palermo, Palermo, Italy
- General Pediatrics Unit, Children's Hospital "G. Di Cristina" - Palermo, Palermo, Italy