Status:
UNKNOWN
Swedish Study of Immunotherapy for Milk Allergy in Children
Lead Sponsor:
Umeå University
Conditions:
Milk Allergy
Eligibility:
All Genders
5-15 years
Phase:
NA
Brief Summary
This trial is a two-armed open randomized controlled trial in children aged 5-15 years with challenge proven Immunoglobulin E (IgE)-associated milk allergy.The purpose is to determine if oral immunoth...
Detailed Description
The underlying hypothesis is that exposure to milk in a controlled way can be delivered safely and induce tolerance to milk.The aim of this trial is to evaluate a specific protocol for oral milk intak...
Eligibility Criteria
Inclusion
- Immunoglobulin E (IgE) milk \>0.1 kU/L
- Allergic reaction within 2 hours after intake of milk protein
- Age 5-15 years
Exclusion
- Uncontrolled asthma, \>12 % increase in Forced Expiratory Volume in 1 second (FEV1) after inhaled bronchodilatator and Asthma Control Test (ACT)\<20
- No allergic reaction at a controlled milk challenge
- Cancer
- Severe immune deficiency
- Autoimmune disease
- Chronic urticaria
- Eosinophil esophagitis
- Pregnancy and breastfeeding
- Ongoing immunotherapy to one or more allergens
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03819556
Start Date
April 20 2018
End Date
October 20 2024
Last Update
May 20 2020
Active Locations (1)
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1
Solveig Röisgård
Östersund, Jämtland Härjedalen, Sweden, 83183