Actively Recruiting
National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2024-07-25
300
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Policlinico San Matteo di Pavia
Lead Sponsor
I
Italian Society of Pediatric Allergy & Immunology - Pediatric Centers
Collaborating Sponsor
AI-Summary
What this Trial Is About
Eosinophilic gastrointestinal disorders (EGIDs) are a heterogeneous group of emerging chronic inflammatory diseases that may affect different gastrointestinal (GI) tracts. Based on the anatomical site involved, EGIDs are distinguished into eosinophilic esophagitis (EoE) and non-esophageal forms, which are subdivided into eosinophilic gastritis (EoG), gastroenteritis (EoGE), and colitis (EoC). EoE is considered the prototype of EGIDs. Since the first description of a case series of patients with EoE, fundamental scientific advances have been achieved, culminating in the redaction of international diagnostic and therapeutic guidelines. In contrast to EoE, non-esophageal forms of EGIDs are still a clinical enigma with evidence limited to a few retrospective studies. In the last decade, an increase in the prevalence of EGIDs has been observed in the pediatric age. Unfortunately, the epidemiology of EGIDs in Italy is still inconsistent and clear estimates are not available. Firstly, this study will allow us to assess and clarify several clinical and epidemiological aspects of pediatric EGIDs, in particular: 1. prevalence and incidence of pediatric EGIDs in Italy, 2. the clinical features and potential phenotypes of pediatric EGIDs with potential impact on therapy and management, 3. diagnostic work-up and adherence to the EoE international guidelines to improve the management, quality of care, and quality of life of affected patients. This study has no ethical problems since EoE patients are treated according to international guidelines and those with non-esophageal EGIDs according to the latest scientific evidence.
CONDITIONS
Official Title
National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 0 to 18 years with eosinophilic gastrointestinal disorders followed at participating centers
- Informed consent signed by a parent or legal guardian and by the patient if older than six years
You will not qualify if you...
- Diagnosis of eosinophilic gastrointestinal disorder made more than five years before study participation
- Diagnosis of eosinophilic esophagitis not following current international guidelines
- Presence of secondary causes of intestinal eosinophilic inflammation such as inflammatory bowel diseases, autoimmune diseases, vasculitis, graft versus host disease, or malignancies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
Research Team
A
Amelia Licari, MD
CONTACT
M
Martina Votto, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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