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Eosinophilic Gastrointestinal DisordersGOLDENNCT05219903

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

An observational study of Eosinophilic Gastrointestinal Disorders and Eosinophilic Esophagitis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 0 to 18 years
How many people
300 participants
Where
1 siteItaly
Study dates
20 Jan 2022to 31 Jan 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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).

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amelia Licari, MD contact

+390382502629

a.licari@smatteo.pv.it

Martina Votto, MD, PhD contact

+390382502629

martinavotto@gmail.com

Italy1 site, 1 recruiting

  • IRCCS Policlinico San Matteo

    Pavia, 27100

    Amelia Licari, MD, +390382502629, a.licari@smatteo.pv.it

    Martina Votto, MD, PhD

    Recruiting

Other trials in Italy

About this study

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:

Read more
  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.

Keywords
Eosinophilic gastrointestinal disorders, Children, Prevalence, Incidence
Medical subject headings
Eosinophilic Esophagitis, Eosinophilic enteropathy, Gastroenteritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence estimates

    1. 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

    Measured: 5 years

  2. Incidence estimates

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

    Measured: 5 years

  3. Prospective epidemiological estimates

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

    Measured: 5 years

Secondary outcomes (3)

  1. Other epidemiological estimates

    1. 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;

    Measured: 5 years

  2. Definition of clinical features and potential phenotypes

    1. To describe the clinical characteristics of Italian patients with EGIDs (risk factors, sex, age, comorbidities, response to therapy, natural history), to identify potential phenotypes;

    Measured: 5 years

  3. Improvement of diagnostic and therapeutic management

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start20 Jan 2022
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
300 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05219903
Sponsor's protocol ID
GOLDEN
Acronym
GOLDEN
Status last verified
Jul 2024
First submitted
21 Jan 2022
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Licari A, Votto M, Scudeller L, De Silvestri A, Rebuffi C, Cianferoni A, Marseglia GL. Epidemiology of Nonesophageal Eosinophilic Gastrointestinal Diseases in Symptomatic Patients: A Systematic Review and Meta-Analysis. J Allergy Clin Immunol Pract. 2020 Jun;8(6):1994-2003.e2. doi: 10.1016/j.jaip.2020.01.060. Epub 2020 Feb 28.

    PubMed 32061717

  • Licari A, Votto M, D'Auria E, Castagnoli R, Caimmi SME, Marseglia GL. Eosinophilic Gastrointestinal Diseases in Children: A Practical Review. Curr Pediatr Rev. 2020;16(2):106-114. doi: 10.2174/1573396315666191022154432.

    PubMed 31642786

  • Votto M, Castagnoli R, De Filippo M, Brambilla I, Cuppari C, Marseglia GL, Licari A. Behavioral issues and quality of life in children with eosinophilic esophagitis. Minerva Pediatr. 2020 Oct;72(5):424-432. doi: 10.23736/S0026-4946.20.05913-7. Epub 2020 Jun 4.

    PubMed 32506880

  • Votto M, Marseglia GL, De Filippo M, Brambilla I, Caimmi SME, Licari A. Early Life Risk Factors in Pediatric EoE: Could We Prevent This Modern Disease? Front Pediatr. 2020 May 29;8:263. doi: 10.3389/fped.2020.00263. eCollection 2020.

    PubMed 32548083

  • Votto M, De Filippo M, Olivero F, Raffaele A, Cereda E, De Amici M, Testa G, Marseglia GL, Licari A. Malnutrition in Eosinophilic Gastrointestinal Disorders. Nutrients. 2020 Dec 31;13(1):128. doi: 10.3390/nu13010128.

    PubMed 33396413

  • Votto M, Raffaele A, De Filippo M, Caimmi S, Brunero M, Riccipetitoni G, Marseglia GL, Licari A. Eosinophilic gastrointestinal disorders in children and adolescents: A single-center experience. Dig Liver Dis. 2022 Feb;54(2):214-220. doi: 10.1016/j.dld.2021.06.027. Epub 2021 Jul 15.

    PubMed 34274254

Questions about this trial

What is this clinical trial studying?

An observational study of Eosinophilic Gastrointestinal Disorders and Eosinophilic Esophagitis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amelia Licari, MD (+390382502629, a.licari@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence estimates (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05219903, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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