Evaluating gastrointestinal eosinophilic disorders in children
National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders
This study looks at how common eosinophilic gastrointestinal disorders are in children to help improve understanding and treatment of these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT05219903 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence and incidence of eosinophilic gastrointestinal disorders (EGIDs) in pediatric patients across multiple centers in Italy. It focuses on conditions such as eosinophilic esophagitis, gastritis, gastroenteritis, and colitis, which are increasingly recognized but poorly understood. By collecting data from patients aged 0-18 years, the study seeks to provide clearer epidemiological insights into these disorders and improve diagnostic and therapeutic guidelines. Informed consent will be obtained from patients and their guardians for participation.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-18 years diagnosed with eosinophilic gastrointestinal disorders.
Not a fit: Patients diagnosed with eosinophilic gastrointestinal disorders more than five years prior or with secondary causes of intestinal eosinophilic inflammation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of eosinophilic gastrointestinal disorders in children.
How similar studies have performed: While there have been some retrospective studies on eosinophilic gastrointestinal disorders, this study aims to fill significant gaps in the understanding of non-esophageal forms, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All EGIDs patients aged 0-18 years and followed at the centers involved in the study will be considered eligible. Informed consent must be obtained from each enrolled patient and signed by a parent/legal guardian and patient (when older than six years). Exclusion Criteria: \- This study will not include patients with: 1. a diagnosis of EGIDs made more than five years before the study participation; 2. a diagnosis of EoE not in line with current international guidelines; 3. a secondary cause of intestinal eosinophilic inflammation (inflammatory bowel diseases, autoimmune diseases, vasculitis, graft versus host disease, malignancies).
Where this trial is running
Pavia
- IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Amelia Licari, MD
- Email: a.licari@smatteo.pv.it
- Phone: +390382502629
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.