Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16
ConditionEgg Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorTampere University Hospital
About this trial
The aim of the study is to determine the efficacy of a 12-month egg oral immunotherapy (OIT) protocol with a cooked whole egg product including yolk and egg white.
Study hypothesis: With this method the risk for severe allergic reaction to egg protein is reduced and the diet can partly or completely be normalized.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 6 to 16 years
Elevated spesific serum IgE to egg (> 5 kU/l) and/or positive skin prick to egg allergen
Positive oral food challenge for egg or anaphylaxis reaction to egg within the 6 months
Diet free from egg in any form
Disqualifiers
Age less than 6 years or more than 16 years
Poor asthma control or uncontrolled asthma
Severe/significant cardiovascular disease
Autoimmune disease
Trial design
Design model
Parallel
Treatments tested in this trial
Egg product including egg white and yolk allergens
Dietary supplementEgg product either meatball or bread roll or bun including egg white and yolk allergens delivered orally in increasing dosages daily.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Egg allergy with asthma with interventionExperimental treatment 1 intervention
Group B: Egg allergy without asthma with interventionExperimental treatment 1 intervention
Group C: Egg allergy with asthma without interventionNo intervention 0 interventions
Group D: Egg allergy without asthma without interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Efficacy of oral egg immunotherapy
Total number of patients who achieved tolerance to egg protein during OIT (negative egg challenge) compared to the number of patients who received only partly tolerance or failed to develop any level of unresponsiveness.
Time frame
Within 12 months of studySecondary outcomes
1
Safety of oral egg immunotherapy
Total number of participants with adverse events, and total number of adverse events evaluating the safety of our method
Time frame
Within 12 months of study2
Specification of adverse reactions during egg OIT in patients without asthma
Subjective evaluation and grading of symptoms from different organ sides during OIT, using visual analogue score 0-10 (VAS) in patients without asthma
Time frame
Within 12 months of study3
Number and severity of anaphylactic reactions during OIT without asthma
Number and severity of anaphylaxis during OIT (Grading of anaphylaxis using Samsons criteria, grade1-5) in patients without asthma
Time frame
Within 12 months of study4
Specification of adverse reactions during OIT in patients with asthma
Subjective evaluation and grading of symptoms from different organ sides during OIT, using visual analogue score 0-10 (VAS) in patients with asthma
Time frame
Within 12 months of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Tampere University Hospital
Lead sponsor
University of Oulu
Collaborator
Oulu University Hospital
Collaborator
Source ClinicalTrials.gov