NCT05219903 National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders
| NCT ID | NCT05219903 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Eosinophilic Gastrointestinal Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-01-20 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-01-20 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Amelia Licari, MD
STUDY DIRECTOR
IRCCS Policlinico San Matteo
Frequently Asked Questions
Who can join the NCT05219903 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 18 Years, studying Eosinophilic Gastrointestinal Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05219903 currently recruiting?
Yes, NCT05219903 is actively recruiting participants. Contact the research team at a.licari@smatteo.pv.it for enrollment information.
Where is the NCT05219903 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT05219903 clinical trial?
NCT05219903 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The principal investigator is Amelia Licari, MD at IRCCS Policlinico San Matteo. The trial plans to enroll 300 participants.