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RecruitingNCT06991881EoStimUpdated May 28, 2025

Eosinophilic Esophagitis: Towards Improved Management

An observational study in Eosinophilic Esophagitis, sponsored by Oslo University Hospital. Recruiting at 2 sites in Norway. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Oslo University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
Up to 17 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Eosinophilic Esophagitis
03

In context

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

This study's planned enrollment of 80 is close to the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.

Browse Eosinophilic Esophagitis studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.

Browse Oslo University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children with newly diagnosed or previously confirmed eosinophilic esophagitis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • chronic severe conditions that preclude general anaestesia
  • lack of consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Target follow-up
15 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • OtherBiobank sampling for new biomarkers

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

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 12 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Not planned due to confidentiality

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Dec 2025, 26 months after the start.

Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's planned 26 months is below that.

Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2025
First posted
May 28, 2025
StartActual
Oct 31, 2023
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
May 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06991881
Lead sponsor
Oslo University Hospital
Collaborators
Helse-Bergen HF
Responsible party
Ketil Størdal (Dr, Oslo University Hospital) — Principal investigator
First posted
May 28, 2025
Start date
Oct 31, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 28, 2025

Study contacts

Ketil Størdal, PhD
Contact
ketil.stordal@medisin.uio.no
+4748272337
Erling Tjora, PhD
Contact
erling.tjora@gmail.com
+47 99588645
Ketil Størdal, PhD
principal investigator · University of Oslo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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