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ClinicalTrials.gov ID

NCT06991881

Lead Sponsor

Oslo University HospitalOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

80Estimated

Last Update Posted

May 28, 2025Actual

Start Date

Oct 31, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

Official Title

Eosinophilic Esophagitis: Towards Improved Management

Brief Summary

The current project aims to improve the care for children and adolescents with eosinophilic esophagitis in a collaborative effort involving pediatric units at Oslo Unversity Hospital and Helse Bergen, Norway. Existing and new non-invasive biomarkers will be explored systematically, aiming to reduce the number of endoscopies and time on restricted diet.

Detailed Description

The overall aim of the current proposal is to improve the care for children and adolescents with EoE and reduce the need for complex elimination diets and repeated endoscopies.

Our objectives are to determine whether

1. at diagnosis the following are predictive for response to food elimination:

   1. history of atopy, symptoms after food intake
   2. eosinophil counts in biopsies and peripheral blood
   3. total IgE, specific IgE, eosinophilic granula proteins, eosinophil progenitor cells in blood
   4. key cytokines (Eotaxin-3, IL-5, IL-13)
   5. eosinophil derived neurotoxin/EDN in oesophageal aspirates, blood samples and feces
   6. circulating microRNAs

2. at follow-up biomarkers collected by non-invasive methods can predict endoscopic and histologic healing

   1. eosinophil counts in esophageal brushes and peripheral blood
   2. total IgE, specific IgE, eosinophilic granula protein, eosinophil progenitor cells
   3. circulating cytokines like eotaxin-3, IL-5, IL-13
   4. eosinophil derived neurotoxin/EDN in esophageal brushes, blood samples and feces
   5. circulating microRNAs

• Eosinophilic Esophagitis

• Biobank sampling for new biomarkers

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• a diagnosis of eosinophilic esophagitis
• suspected but not yet confirmed eosinophilic esophagitis

Exclusion Criteria:

• chronic severe conditions that preclude general anaestesia
• lack of consent

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Helse-Bergen HFOTHER

ketsto@ous-hf.no