Actively Recruiting

Age: 0Years - 18Years
All Genders
NCT05219903

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

Age: 0Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Actively Recruiting

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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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