NCT06206616Recruiting
Liver Steatosis in Pediatric CD Patients
Liver Steatosis in Pediatric Celiac Disease Patients: Exploring the Epidemiological and Pathophysiological Features of an Underestimated Condition
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 91 (estimated)
- First submitted
- 4 Jan 2024
- Start date
- 1 Nov 2027
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Palermo
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06206616
What you commit to
- Study type: Observational
- Planned participants: 91
- From 1 Nov 2027 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients undergoing chemotherapy and/or radiotherapy.
Other illness
- 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
Age
- age \<1 and \>14 years;
Other
- self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;
Who the study is looking for
- Age \>1 and \<14 years
- Celiac Disease diagnosis according European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria
Age in the registry: 1 year to 14 years · Sex: All
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina" Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| General Pediatrics Unit, Children's Hospital "G. Di Cristina" Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.