Celiac Disease in ChildrenNon-Alcoholic Fatty Liver Disease
Investigational drug(s) / intervention(s)
Gluten-free diet
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.
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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
14 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Historical Nonalcoholic Fatty Liver Disease Prevalence in Pediatric Celiac Disease Patients before Gluten Free Diet — Retrospective (years 2000-2023) We will review all the clinical charts of historical Celiac Disease pediatric patients to identify the number of patients suffering from Nonalcoholic Fatty Liver Disease before the start of gluten free diet.
Hepatic steatosis will be ascertained by ultrasound examination and classified as follows: absent (score 0), present (score 1)
Historical Nonalcoholic Fatty Liver Disease Prevalence in Pediatric Celiac Disease Patients after Gluten Free Diet — Retrospective (years 2000-2023) We will review all the clinical charts of historical Celiac Disease pediatric patients to identify the number of patients suffering from Nonalcoholic Fatty Liver Disease after the start of gluten free diet (at least 1 year of diet).
Hepatic steatosis will be ascertained by ultrasound examination and classified as follows: absent (score 0), present (score 1)
Historical Nonalcoholic Fatty Liver Disease Degree in Pediatric Celiac Disease Patients before Gluten Free Diet — Retrospective (years 2000-2023) We will review all the clinical charts of historical Celiac Disease pediatric patients to identify the steatosis degree of patients suffering from Nonalcoholic Fatty Liver Disease before the start of gluten free diet.
Hepatic steatosis will be ascertained by ultrasound examination and classified as follows: when the echostructure of the liver is normal; mild (score 1 = mild), when there is a mild and diffuse increase in hepatic echogenicity, with normal visualization of the portal vein wall and diaphragm; moderate (score 2 = moderate), in case of moderate increase in hepatic echogenicity, with slightly altered appearance of the portal vein wall and diaphragm; severe (score 3 = severe), in case of marked increase in hepatic echogenicity, with poor or absent visualization of the wall of the portal vein, the diaphragm and the posterior part of the right hepatic lobe
Historical Nonalcoholic Fatty Liver Disease Degree in Pediatric Celiac Disease Patients after Gluten Free Diet — Retrospective (years 2000-2023) We will review all the clinical charts of historical Celiac Disease pediatric patients to identify the steatosis degree of patients suffering from Nonalcoholic Fatty Liver Disease after the start of gluten free diet (at least 1 year of diet).
Hepatic steatosis will be ascertained by ultrasound examination and classified as follows: when the echostructure of the liver is normal; mild (score 1 = mild), when there is a mild and diffuse increase in hepatic echogenicity, with normal visualization of the portal vein wall and diaphragm; moderate (score 2 = moderate), in case of moderate increase in hepatic echogenicity, with slightly altered appearance of the portal vein wall and diaphragm; severe (score 3 = severe), in case of marked increase in hepatic echogenicity, with poor or absent visualization of the wall of the portal vein, the diaphragm and the posterior part of the right hepatic lobe
Historical Nonalcoholic Fatty Liver Disease Prevalence Change in Pediatric Celiac Disease Patients — Retrospective (years 2000-2023); 1 year of diet A comparison between pre and post gluten free diet (1 year of diet) Nonalcoholic Fatty Liver Disease evidence will be performed in all historical pediatric celiac disease patients who have undergone an abdominal ultrasound both before and after the introduction of the GFD. Hepatic steatosis will be ascertained by ultrasound examination and classified as follows: absent (score 0), present (score 1).
Difference will be considered significant for p\<0.05.
Historical Nonalcoholic Fatty Liver Disease Degree Change in Pediatric Celiac Disease Patients — Retrospective (years 2000-2023); 1 year of diet A comparison between pre and post gluten free diet (1 year of diet) Nonalcoholic Fatty Liver Disease degree will be performed in all historical pediatric celiac disease patients who have undergone an abdominal ultrasound both before and after the introduction of the GFD.
Hepatic steatosis will be ascertained by ultrasound examination and classified as reported in outcomes 3 and 4.
Difference will be considered significant for p\<0.05.
Trial sites (2)
Facility
City
Region
Status
Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina"
Palermo
Palermo
Recruiting
General Pediatrics Unit, Children's Hospital "G. Di Cristina"
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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