Liver fat in children with celiac disease
Liver Steatosis in Pediatric Celiac Disease Patients: Exploring the Epidemiological and Pathophysiological Features of an Underestimated Condition
This study will try to see if children with celiac disease have fatty liver and how their liver tests and markers change with a gluten-free diet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 91 (estimated) |
| Ages | 1 Year to 14 Years |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Palermo, Palermo and 1 other locations) |
| Trial ID | NCT06206616 on ClinicalTrials.gov |
What this trial studies
This observational study will examine how often and in what form liver steatosis occurs in children with celiac disease, including related measures of intestinal permeability and inflammatory cytokines. It will enroll children aged 1–14 with celiac disease diagnosed according to ESPGHAN criteria and collect clinical data, blood tests, and liver imaging and biomarker measurements. Investigators will relate liver findings to nutritional status and follow liver test changes after starting or maintaining a gluten-free diet. Children with active infections, other chronic gastrointestinal or systemic diseases, cancer, or undergoing chemotherapy/radiotherapy are excluded.
Who should consider this trial
Good fit: Children aged 1–14 years with a confirmed celiac disease diagnosis by ESPGHAN criteria who can attend visits at the study site and follow the gluten-free diet guidance are ideal candidates.
Not a fit: Children with other chronic liver or gastrointestinal diseases, active bacterial/parasitic infections, cancer, immunodeficiency, or those unwilling to reintroduce gluten for diagnostic purposes are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could help find children with celiac disease who have fatty liver earlier so they can get appropriate dietary guidance and liver monitoring.
How similar studies have performed: Adult studies have shown a non-random association between celiac disease and NAFLD, but pediatric data are limited and have produced mixed results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Palermo, Palermo and 1 other locations
- Gastroenterological Paediatrics, Children's Hospital "G. Di Cristina" — Palermo, Palermo, Italy (Recruiting)
- General Pediatrics Unit, Children's Hospital "G. Di Cristina" — Palermo, Palermo, Italy (Recruiting)
Study contacts
- Study coordinator: Aurelio Seidita, MD
- Email: aurelio.seidita@unipa.it
- Phone: 00390916802764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.