Eosinophilic Esophagitis: Towards Improved Management (EoStim)

May 27, 2025 updated by: Ketil Størdal, Oslo University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

80

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

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children with newly diagnosed or previously confirmed eosinophilic esophagitis.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Collaborators

Helse-Bergen HF

Investigators

  • Principal Investigator: Ketil Størdal, PhD, University of Oslo

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)

October 31, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

May 27, 2025

First Posted (Actual)

May 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planned due to confidentiality

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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