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NCT Number: NCT06991881

Eosinophilic Esophagitis: Towards Improved Management

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.

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Key information

Conditions

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

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

About this study

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

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

history of atopy, symptoms after food intake
eosinophil counts in biopsies and peripheral blood
total IgE, specific IgE, eosinophilic granula proteins, eosinophil progenitor cells in blood
key cytokines (Eotaxin-3, IL-5, IL-13)
eosinophil derived neurotoxin/EDN in oesophageal aspirates, blood samples and feces
circulating microRNAs
at follow-up biomarkers collected by non-invasive methods can predict endoscopic and histologic healing

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Biobank sampling for new biomarkers

Other

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

Primary outcomes

Active eosinophilic esophagitis (>15 eosinophils per high-power field)

Time frame: 12 months

The eosinophil counts in a biopsy is used to classify active vs non-active eosinophilic esophagitis, and biomarkers are analysed using biopsy the gold standard to classify active vs inactive disease.

Study contacts

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

Erling Tjora, PhD

CONTACT

[email protected]

+47 99588645

Ketil Størdal, PhD

CONTACT

[email protected]

+4748272337

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

Helse-Bergen HF

Registry information

Acronym: EoStim

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: May 28, 2025
Registry last updated: May 28, 2025

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.

Published trials that share one or more normalized conditions with this study.

Recruiting