Actively Recruiting
Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16
Led by Tampere University Hospital · Updated on 2024-04-10
60
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
Tampere University Hospital
Lead Sponsor
U
University of Oulu
Collaborating Sponsor
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 16 years
- Elevated specific 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 last 6 months
- Diet free from egg in any form
You will not qualify if you...
- Age less than 6 years or more than 16 years
- Poor asthma control or uncontrolled asthma
- Severe or significant cardiovascular disease
- Autoimmune disease
- Malignancy
- Use of beta blockers, ACE inhibitors, or MAO inhibitors
- Poor compliance
- Fear of immunotherapy
- Desensitization to alfa-gal-protein (mammalian meat allergy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive daily oral immunotherapy with a cooked whole egg product, starting from a very low dose and increasing every 1 to 2 weeks until a target dose is reached. This treatment lasts for 12 months and includes preparation and instructions for emergency treatment if needed.
Initial dosage given at the hospital outpatient clinic; blood samples, skin prick tests, lung function tests, and exhaled nitric oxide levels at baseline, 6 months, and 12 months
Trial Site Locations
Total: 2 locations
1
Oulu University Hospital
Oulu, Finland, 90230
Actively Recruiting
2
Tampere University Hospital
Tampere, Finland, 33520
Actively Recruiting
Research Team
R
Rüdiger Schultz, MD., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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