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

July 24, 2024 updated by: Amelia Licari, Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • IRCCS Policlinico San Matteo
        • Contact:
        • Principal Investigator:
          • Martina Votto, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

EoE and EGIDs Definition: Based on current international guidelines, EoE diagnosis requires the presence of more than 15 eos/HPF in endoscopically obtained esophageal biopsies.5 In contrast, the diagnosis of non-esophageal EGIDs should meet the following criteria:

  • Chronic/recurrent GI symptoms unresponsive to standard therapies,
  • A prevalent eosinophilic intestinal inflammation,
  • Exclusion of secondary causes of intestinal eosinophilia (e.g., intestinal parasitosis, chronic inflammatory bowel disease, vasculitis, autoimmune diseases, graft versus host disease, tumors).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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
5 years
Prospective epidemiological estimates
Time Frame: 5 years
a) To estimate the cumulative incidence of EGIDs (new diagnosis of EGIDs) over the study period.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
5 years
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;
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborators

Italian Society of Pediatric Allergy & Immunology - Pediatric Centers

Investigators

  • Study Director: Amelia Licari, MD, IRCCS Policlinico San Matteo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOLDEN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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