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Actively Recruiting

Phase Not Applicable
Age: 6Years - 16Years
All Genders
ID05740163

12-Month Oral Immunotherapy Using Cooked Whole Egg for Children With Egg Allergy Aged 6 to 16

Led by Tampere University Hospital · Updated on 2024-04-10

60

Participants Needed

2

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a 12-month oral immunotherapy OIT protocol using a cooked whole egg product, including both yolk and egg white, for children aged 6 to 16 with egg allergy. This study aims to see if this natural and inexpensive approach can reduce the risk of severe allergic reactions and help normalize the diet. The trial also investigates differences in treatment effects between children with and without asthma, including asthma symptom control during the therapy. Participants are divided into groups based on asthma status and then randomized to receive either the egg oral immunotherapy or to a follow-up group without treatment for 12 months. The immunotherapy involves daily oral doses of a cooked whole-egg product, starting with a very small amount and gradually increasing every 1 to 2 weeks until reaching a higher maintenance dose. The initial dose is given in a hospital outpatient clinic, and participants are trained to manage allergic reactions and carry emergency medication. Those receiving immunotherapy also take daily antihistamines during the maintenance phase. Throughout the study, participants undergo blood tests, skin prick tests, lung function tests, and measurements of exhaled nitric oxide before treatment and at 6 and 12 months. Researchers will assess the effectiveness of the therapy by measuring changes in allergic response thresholds and immune system markers. Safety and side effects, including allergic reactions and asthma symptoms, are closely monitored over the 12 months. After the initial 12 months, participants in the follow-up group can choose to start the immunotherapy treatment.

CONDITIONS

Brief Title

Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16

Research Team

R

Rüdiger Schultz, MD., PhD

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