NCT06991881

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

February 17, 2025

Last Update Submit

May 27, 2025

Conditions

Outcome Measures

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.

    12 months

Interventions

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

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with newly diagnosed or previously confirmed eosinophilic esophagitis.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haukeland University Hospital

Bergen, Norway

RECRUITING

OsloUH

Oslo, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (EDTA), serum samples, oesophageal biopsies and brushes, stool samples.

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ketil Størdal, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ketil Størdal, PhD

CONTACT

Erling Tjora, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 17, 2025

First Posted

May 28, 2025

Study Start

October 31, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Not planned due to confidentiality

Locations