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NCT Number: NCT05219903

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

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.

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Key information

Conditions

Eosinophilic Gastrointestinal Disorders Digestive System Diseases Eosinophilia Eosinophilic Colitis Eosinophilic Esophagitis Eosinophilic Gastritis or Gastroenteritis Eosinophilic enteropathy Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Amelia Licari, MD

CONTACT

[email protected]

+390382502629

Martina Votto, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • a diagnosis of EGIDs made more than five years before the study participation;
  • a diagnosis of EoE not in line with current international guidelines;
  • a secondary cause of intestinal eosinophilic inflammation (inflammatory bowel diseases, autoimmune diseases, vasculitis, graft versus host disease, malignancies).

Treatment and study plan

Primary outcomes

  1. Prevalence estimates

    Time frame: 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

  2. Incidence estimates

    Time frame: 5 years

    b) If available the cumulative incidence (new EGIDs cases) may be derived, as a subgroup analysis of the primary endpoint

  3. Prospective epidemiological estimates

    Time frame: 5 years

    a) To estimate the cumulative incidence of EGIDs (new diagnosis of EGIDs) over the study period.

Secondary outcomes

  1. Other epidemiological estimates

    Time frame: 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;

  2. Definition of clinical features and potential phenotypes

    Time frame: 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;

  3. Improvement of diagnostic and therapeutic management

    Time frame: 5 years

    c) To define shared diagnostic-therapeutic management and verify the adherence of enrolled centers to the international EoE guidelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Amelia Licari, MD

CONTACT

[email protected]

+390382502629

Martina Votto, MD, PhD

CONTACT

[email protected]

+390382502629

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Italian Society of Pediatric Allergy & Immunology - Pediatric Centers

Registry information

Acronym: GOLDEN

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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