Evaluating growth in children with celiac disease on a gluten-free diet
Entities and Variables Related to Catch-up Growth in Pediatric Patients With Celiac Disease (CD) on a Gluten-free Diet (GFD)
This study looks at how a gluten-free diet affects the growth of children with celiac disease to see what factors might help them grow better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ASST Fatebenefratelli Sacco Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06364735 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the factors influencing catch-up growth in children diagnosed with celiac disease who have been on a gluten-free diet. It will analyze anonymized medical records from patients treated at V. Buzzi Children's Hospital in Milan over a 10-year period, focusing on a sample size of 900 patients. The study will explore various variables that may impact growth outcomes in these children, providing insights into their long-term health.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with celiac disease at V. Buzzi Children's Hospital between January 2010 and December 2020.
Not a fit: Patients with unclear duodenal histological alterations, additional chronic illnesses, or IgA deficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify key factors that promote healthy growth in children with celiac disease, leading to improved dietary and clinical management.
How similar studies have performed: While this study focuses on a specific population and condition, similar observational studies have shown success in understanding growth patterns in children with dietary restrictions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * celiac disease diagnosis established at the V. Buzzi Children\'s Hospital in Milan between January 2010 and December 2020, excluding the extremes, in accordance with the ESPGHAN 2012 or 2020 recommendations. Exclusion Criteria: * patients with unclear or non-specific duodenal histological alterations (e.g., atrophy with unavailable or negative specific antibodies for celiac disease); * patients with additional chronic illnesses; * absence of the data required for the study; * patients with IgA deficiency, defined as IgA \<20 mg/dl in children \<3 years old or with levels that are below normal for their age.
Where this trial is running
Milan
- ASST Fatebenefratelli Sacco — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Groppali, MD
- Email: elena.groppali@asst-fbf-sacco.it
- Phone: 00390263631
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.