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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-20

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease

NCT02190513

Celiac Disease Eosinophilic Esophagitis

COMPLETED

Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders

NCT01212016

Eosinophilic Gastroenteritis Eosinophilic Esophagitis

TERMINATED

Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

NCT03320369

Eosinophilic Gastroenteritis

COMPLETED NA

A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form

NCT05528900

Food Protein Induced Enterocolitis Syndrome (FPIES)

RECRUITING NA

Non-Immunoglobulin E-mediated Food Allergies in Children

NCT04462978

Non IgE Mediated Food Allergy Food Protein-Induced Enteropathy Food Protein-Induced Proctocolitis +2 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eosinophilic Gastrointestinal Disorders Eosinophilic Esophagitis Eosinophilic Gastritis or Gastroenteritis Eosinophilic Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No