Eosinophilic Esophagitis: Towards Improved Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biobank sampling for new biomarkers.
- Who it may be relevant to
- Registry conditions: Eosinophilic Esophagitis. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Other Biobank sampling for new biomarkers
Using biopsies as the gold standard, the project aims towards validating non-invasive biomarkers as specified previously against biopsies.
Primary outcome measures
- Active eosinophilic esophagitis (>15 eosinophils per high-power field) [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 2 centers
- Haukeland University Hospital — Bergen
- OsloUH — Oslo
Identifiers
NCT: NCT06991881 · 201046