National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders

Recruiting

• Conditions: Eosinophilic Gastrointestinal Disorders; Eosinophilic Colitis; Eosinophilic Gastritis or Gastroenteritis; Eosinophilic Esophagitis

• Registration Number: NCT05219903
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence estimates	5 years	b) If available the cumulative incidence (new EGIDs cases) may be derived, as a subgroup analysis of the primary endpoint
Prospective epidemiological estimates	5 years	a) To estimate the cumulative incidence of EGIDs (new diagnosis of EGIDs) over the study period.
Prevalence estimates	5 years	a) To estimate the EGIDs prevalence in patients with gastrointestinal symptoms undergoing upper and lower GI endoscopy, to verify whether the global increase of EGIDs also affects the Italian reality

Secondary Outcome Measures

Name	Time	Method
Improvement of diagnostic and therapeutic management	5 years	c) To define shared diagnostic-therapeutic management and verify the adherence of enrolled centers to the international EoE guidelines.
Definition of clinical features and potential phenotypes	5 years	b) To describe the clinical characteristics of Italian patients with EGIDs (risk factors, sex, age, comorbidities, response to therapy, natural history), to identify potential phenotypes;
Other epidemiological estimates	5 years	a) To compare the cumulative incidence of EGIDs observed in the prospective with the data from the retrospective study (if available) and those available in the literature, to verify the increase of EGIDs, previously observed in a few US observational studies;

Trial Locations

Locations (1)

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy