Eosinophilic EsophagitisEoStimNCT06991881
Eosinophilic Esophagitis: Towards Improved Management
An observational study of Eosinophilic Esophagitis, run by Oslo University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Biobank sampling for new biomarkers
- How many people
- 80 participants
- Where
- 2 sitesNorway
- Study dates
- 31 Oct 2023to 31 Dec 2025
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with newly diagnosed or previously confirmed eosinophilic esophagitis.
Who may be able to join
- a diagnosis of eosinophilic esophagitis
- suspected but not yet confirmed eosinophilic esophagitis
Who cannot join
- chronic severe conditions that preclude general anaestesia
- lack of consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Erling Tjora, PhD, erling.tjora@gmail.com
Eirik Kaasa, MD, eirik.volckmar.kaasa@helse-bergen.no
- Recruiting
OsloUH
Oslo
Ketil Størdal, PhD, ketsto@ous-hf.no
Charlotte Brun, PhD, acbrun@gmail.com
About this study
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
- 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
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Biobank sampling for new biomarkers
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobank sampling for new biomarkersOther
Using biopsies as the gold standard, the project aims towards validating non-invasive biomarkers as specified previously against biopsies.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start31 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse-Bergen HF
- Responsible party
- Principal investigator, Ketil Størdal, Oslo University Hospital
- Investigators
- Ketil Størdal, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991881
- Sponsor's protocol ID
- 201046
- Acronym
- EoStim
- Status last verified
- May 2025
- First submitted
- 17 Feb 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned due to confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophilic Esophagitis: Towards Improved Management
- ClinicalTrials.gov ID
- NCT06991881
- Acronym / sponsor ID
- EoStim / 201046
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse-Bergen HF
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with newly diagnosed or previously confirmed eosinophilic esophagitis.
Key inclusion criteria (2 listed)
- a diagnosis of eosinophilic esophagitis
- suspected but not yet confirmed eosinophilic esophagitis
Key exclusion criteria (2 listed)
- chronic severe conditions that preclude general anaestesia
- lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobank sampling for new biomarkersUsing biopsies as the gold standard, the project aims towards validating non-invasive biomarkers as specified previously against biopsies. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No. Not planned due to confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ketil Størdal, PhD principal investigator
University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ketil Størdal, PhD (+4748272337, ketil.stordal@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active eosinophilic esophagitis (>15 eosinophils per high-power field) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025; AzTrials last refreshed its copy on 3 Nov 2026.