NCT04331522

Brief Summary

A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
163mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress36%
Oct 2018Oct 2039

Study Start

First participant enrolled

October 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
18.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2038

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2039

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

20 years

First QC Date

March 31, 2020

Last Update Submit

July 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The association of allergy tests with the result of allergen provocation

    The value of specific IgE and SPT to predict the outcome of a allergen provocation

    5 years

Study Arms (15)

Antibiotics

Children aged 0-18 years investigated for allergy to antibiotics

Diagnostic Test: Oral provocation test

Milk

Children aged 0-18 years investigated for allergy to milk

Diagnostic Test: Oral provocation test

Egg

Children aged 0-18 years investigated for allergy to egg

Diagnostic Test: Oral provocation test

Peanut

Children aged 0-18 years investigated for allergy to peanut

Diagnostic Test: Oral provocation test

Hazelnut

Children aged 0-18 years investigated for allergy to hazelnut

Diagnostic Test: Oral provocation test

Sesame

Children aged 0-18 years investigated for allergy to sesame

Diagnostic Test: Oral provocation test

Wheat

Children aged 0-18 years investigated for allergy to wheat

Diagnostic Test: Oral provocation test

walnut

Children aged 0-18 years investigated for allergy to walnut

Diagnostic Test: Oral provocation test

cashew

Children aged 0-18 years investigated for allergy to cashew

Diagnostic Test: Oral provocation test

Pistachio

Children aged 0-18 years investigated for allergy to pistachio

Diagnostic Test: Oral provocation test

Almond

Children aged 0-18 years investigated for allergy to almond

Diagnostic Test: Oral provocation test

Soy

Children aged 0-18 years investigated for allergy to soy

Diagnostic Test: Oral provocation test

Fish

Children aged 0-18 years investigated for allergy to fish

Diagnostic Test: Oral provocation test

Shellfish

Children aged 0-18 years investigated for allergy to shellfish

Diagnostic Test: Oral provocation test

Poppy seed

Children aged 0-18 years investigated for allergy to poppy seed

Diagnostic Test: Oral provocation test

Interventions

Oral provocation testDIAGNOSTIC_TEST

Titrated provocation with allergen

AlmondAntibioticsEggFishHazelnutMilkPeanutPistachioPoppy seedSesameShellfishSoyWheatcashewwalnut

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children referred to the department of pediatrics for investigation of allergy to foods or antibiotics

You may qualify if:

  • clinical suspicion of allergy to foods or antibiotics informed concent -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hans Christian Andersen Children's Hospital

Odense, Odense C, 5000, Denmark

RECRUITING

Related Publications (2)

  • Gradman J, Petersen BT, Halken S. Oral food challenge with raw egg: Sixty-minute- compared with 30-minute dosing interval. Clin Exp Allergy. 2022 Sep;52(9):1114-1117. doi: 10.1111/cea.14187. Epub 2022 Jul 4. No abstract available.

  • Petersen BT, Gradman J. Prospective study of 5-day challenge with penicillins in children. BMJ Paediatr Open. 2020 Aug 4;4(1):e000734. doi: 10.1136/bmjpo-2020-000734. eCollection 2020.

Central Study Contacts

Josefine Gradman, phd

CONTACT

Susanne Halken, DMSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
17 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, phd

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 2, 2020

Study Start

October 1, 2018

Primary Completion (Estimated)

October 1, 2038

Study Completion (Estimated)

October 1, 2039

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations