Studies liver fat buildup in children with celiac disease
Observes fatty liver disease in children with celiac disease, including gluten-free diet effects.
Key facts
- Who runs it
- University of Palermo
- Where
- Palermo, ItalySee the 2 sites
- Trial code
- Registry title
- Liver Steatosis in Pediatric CD Patients
- Status
- Recruiting
- People taking part
- 91 people, planned
- Starts
- 1 Nov 2027
- Expected to end
- 30 Sept 2028
- Type of study
- Observational
- Treatments tested
- Gluten-free diet
- Record updated
- 1 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with celiac disease, to study fatty liver and its link with a gluten-free diet.
- Age
- Older than 1 year and younger than 14 years (1 Year to 14 Years).
- Sex
- Boys and girls can both join.
- Disease stage
- Celiac disease diagnosed according to the ESPGHAN criteria.
- Earlier treatment
- Children who stopped eating gluten or wheat on their own and refuse to eat it again for diagnosis cannot join. People undergoing chemotherapy or radiotherapy cannot join.
Main reasons for not taking part
- Self-excluded gluten or wheat from the diet and refusal to reintroduce it for diagnosis before the study
- Bacterial or parasitic infections
- Chronic inflammatory bowel disease or other diseases of the digestive system, such as serious liver disease
- Nervous system diseases, immune deficiencies, or impairments that limit physical activity
- Cancer, or chemotherapy or radiotherapy
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Age >1 and <14 years
- Celiac Disease diagnosis according European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria
Who cannot take part
- patients undergoing chemotherapy and/or radiotherapy
- 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 <1 and >14 years
- self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 14 years old?
Where in Italy
- Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina"Palermo, ItalyContact: Francesca Cavataio, MDTaking people
- General Pediatrics Unit, Children's Hospital "G. Di Cristina"Palermo, ItalyContact: Salvatore Accomando, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Celiac Disease Children
Pediatric patients affected by newly diagnosed CD according to the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria will be evaluated before the start of gluten-free diet and after 6 months of gluten-free diet.
Treatment: Gluten-free diet
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Liver Steatosis in Pediatric Celiac Disease Patients: Exploring the Epidemiological and Pathophysiological Features of an Underestimated Condition
- Plain-language title
- Studies liver fat buildup in children with celiac diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06206616, who can take part
- Record updated
- 1 May 2026