Wheat Allergy Clinical Trial
Official title:
Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
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).
Status | Recruiting |
Enrollment | 15 |
Est. completion date | September 10, 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 16 Years |
Eligibility | Inclusion Criteria: 1. Age 2-16 years 2. Personal history of IgE-mediated allergy to wheat with unequivocal allergic reaction one year before study entry, and 1. Positive SPT in wheat (> 3 mm), and/or 2. Wheat specific IgE f4 > 0.35 kUa/L, and 3. A positive Oral Food Challenge (OFC) to wheat, with the exception of patients who report a recent reaction (< 3 months before study entry) after the consumption of wheat products 3. Signed written consent form of the parents. Exclusion Criteria: 1. Severe persistent or uncontrolled bronchial asthma or other lung disease (other than asthma), and/or 2. Recent personal history (over the past 12 months) of severe anaphylactic reaction following wheat consumption, for which Intensive Care Unit (ICU) hospitalization was required, and/or 3. Patients on specific immunotherapy, subcutaneous (SCIT) or sublingual (SLIT) or any other form of current immunotherapy or treatment with other biological agents, and/or 4. Personal history of anaphylaxis due to wheat-dependent exercise induced anaphylaxis, and/or 5. Patients with celiac disease or diagnosis other than IgE-mediated wheat allergy (eg eosinophilic gastrointestinal diseases), and/or 6. Patients with cardiovascular disease or other significant systemic disease, and/or 7. Patients presenting severe anaphylactic reaction to very low doses of wheat (eg. after administration of the 1st or 2nd dose during the baseline OFC). |
Country | Name | City | State |
---|---|---|---|
Greece | Department of Allergy and Clinical Immunology, 2nd Pediatric Clinic, General Children's Hospital P-A Kyriakou | Athens |
Lead Sponsor | Collaborator |
---|---|
Athens General Children's Hospital "Pan. & Aglaia Kyriakou" |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wheat allergic children achieving desensitization after 1 year of wheat home SOTI. | The rate of wheat allergic children achieving desensitization after 1 year of wheat home SOTI. | 1 year | |
Secondary | Variability of Skin Prick Tests (SPTs) pre and post 1-year SOTI intervention | Determination of Skin Prick Tests (SPTs) of wheat allergic children pre and post 1-year SOTI intervention | 1 year | |
Secondary | Total IgE, wheat specific IgE levels (f4, f79, f98, f416, f433) pre and post 1-year SOTI intervention | Determination of wheat allergic patients' total IgE, wheat specific IgE levels (f4, f79, f98, f416, f433) pre and post 1-year SOTI intervention | 1 year | |
Secondary | Wheat basophil activation test (BAT) pre and post 1-year SOTI intervention | Determination of wheat allergic patients' basophils activation pre and post 1-year SOTI intervention via Basophil Activation Test (BAT) | 1 year |
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