Allergen Provocations- HCA Children's Hospital

• Sponsor: Josefine Gradman (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04331522
• Collaborator: (none)
• Enrollment: 8,000
• Location: 1
• Anticipated Duration (Months): 252
• Patients Per Site Per Month: 31.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Allergy in Children	Diagnostic Test: Oral provocation test

Detailed Description

The purpose of the study is to investigate the impact of co-morbidities, history, and allergen tests on the outcome of allergen provocation tests.

Subjects are children aged 0-18 years old investigated for allergy to foods or antibiotics. Data entered in the database are demographics, co-morbidities, symptoms, SPT, specific IgE and details of the allergen provocations.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 8000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Allergen Provocations at Hans Christian Andersen Children's Hospital
• Actual Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Oct 1, 2038
• Anticipated Study Completion Date: Oct 1, 2039

Arms and Interventions

Arm	Intervention/Treatment
Antibiotics Children aged 0-18 years investigated for allergy to antibiotics	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Milk Children aged 0-18 years investigated for allergy to milk	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Egg Children aged 0-18 years investigated for allergy to egg	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Peanut Children aged 0-18 years investigated for allergy to peanut	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Hazelnut Children aged 0-18 years investigated for allergy to hazelnut	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Sesame Children aged 0-18 years investigated for allergy to sesame	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Wheat Children aged 0-18 years investigated for allergy to wheat	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
walnut Children aged 0-18 years investigated for allergy to walnut	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
cashew Children aged 0-18 years investigated for allergy to cashew	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Pistachio Children aged 0-18 years investigated for allergy to pistachio	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Almond Children aged 0-18 years investigated for allergy to almond	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Soy Children aged 0-18 years investigated for allergy to soy	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Fish Children aged 0-18 years investigated for allergy to fish	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Shellfish Children aged 0-18 years investigated for allergy to shellfish	Diagnostic Test: Oral provocation test; Titrated provocation with allergen
Poppy seed Children aged 0-18 years investigated for allergy to poppy seed	Diagnostic Test: Oral provocation test; Titrated provocation with allergen

Outcome Measures

Primary Outcome Measures

1. The association of allergy tests with the result of allergen provocation [5 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

clinical suspicion of allergy to foods or antibiotics informed concent -

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hans Christian Andersen Children's Hospital	Odense	Odense C	Denmark	5000

Sponsors and Collaborators

• Josefine Gradman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Josefine Gradman, Consultant, phd, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT04331522
• Other Study ID Numbers: HCA-AP
• First Posted: Apr 2, 2020
• Last Update Posted: Apr 2, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 2, 2020