Actively Recruiting
Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
Led by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" · Updated on 2024-07-30
15
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an observational pilot study investigating the effectiveness, safety and specific immunological mechanisms of Specific Oral Tolerance Induction (SOTI) in children with IgE-mediated wheat allergy. The study will include 10 patients with persistent IgE-mediated allergy to wheat, who will undergo 1-year home SOTI. Moreover, 5 patients with IgE-mediated allergy to wheat will be followed for 1-year period after their diagnosis, without any intervention. Well-cooked wheat spaghetti will be given daily to patients with a programmed weekly dose increment for 27 weeks (up-dosing phase). Subsequently, wheat protein maintenance dose will be received daily for additional 6 months (maintenance phase), while afterwards patients will be clinically assessed and a 2nd OFC at a higher cumulative dose of wheat protein will be performed, in order to assess patients' desensitization to wheat. Skin Prick Tests (SPTs) to wheat, blood sampling for the determination of total IgE, wheat specific IgEs and wheat Basophil Activation Test (BAT) will be performed at baseline, when patients reach the maintenance dose and before the 2nd OFC. Regarding historical control group the same testing will be performed at baseline and at re-evaluation (post 12 months).
CONDITIONS
Official Title
Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and 16 years
- Personal history of IgE-mediated wheat allergy with clear allergic reaction within the last year
- Positive skin prick test to wheat larger than 3 mm and/or wheat specific IgE greater than 0.35 kUa/L
- Positive oral food challenge to wheat, except for recent reactions within 3 months
- Signed written consent from parents or legal guardians
You will not qualify if you...
- Severe persistent or uncontrolled asthma or other lung diseases
- Severe anaphylactic reaction to wheat requiring intensive care in the past 12 months
- Current treatment with subcutaneous or sublingual immunotherapy or any biologic agents
- History of anaphylaxis due to wheat-dependent exercise-induced anaphylaxis
- Diagnosis of celiac disease or other non-IgE-mediated gastrointestinal diseases
- Cardiovascular or other significant systemic diseases
- Severe anaphylactic reactions to very low doses of wheat during baseline testing
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Allergy and Clinical Immunology, 2nd Pediatric Clinic, General Children's Hospital P-A Kyriakou
Athens, Greece, 11527
Actively Recruiting
Research Team
N
Nikolaos Kitsioulis, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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