Liver fat in children with celiac disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.