Eosinophilic Esophagitis: Towards Improved Management

NCT ID: NCT06991881

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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

Conditions

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Eosinophilic Esophagitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biobank sampling for new biomarkers

Using biopsies as the gold standard, the project aims towards validating non-invasive biomarkers as specified previously against biopsies.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse-Bergen HF

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ketil Størdal

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ketil Størdal, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

OsloUH

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Ketil Størdal, PhD

Role: CONTACT

+4748272337

Erling Tjora, PhD

Role: CONTACT

+47 99588645

Facility Contacts

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Erling Tjora, PhD

Role: primary

Eirik Kaasa, MD

Role: backup

Ketil Størdal, PhD

Role: primary

Charlotte Brun, PhD

Role: backup

Other Identifiers

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201046

Identifier Type: -

Identifier Source: org_study_id

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