Status:
RECRUITING
Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
Lead Sponsor:
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Conditions:
Wheat Allergy
Eligibility:
All Genders
2-16 years
Brief Summary
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 aller...
Detailed Description
This is an observational pilot study investigating the effectiveness, safety and specific immunological mechanisms of Specific Oral Tolerance Induction (SOTI) in children aged 2-16 years with IgE-medi...
Eligibility Criteria
Inclusion
- Age 2-16 years
- Personal history of IgE-mediated allergy to wheat with unequivocal allergic reaction one year before study entry, and
- Positive SPT in wheat (\> 3 mm), and/or
- Wheat specific IgE f4 \> 0.35 kUa/L, and
- 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
- Signed written consent form of the parents.
Exclusion
- Severe persistent or uncontrolled bronchial asthma or other lung disease (other than asthma), and/or
- 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
- Patients on specific immunotherapy, subcutaneous (SCIT) or sublingual (SLIT) or any other form of current immunotherapy or treatment with other biological agents, and/or
- Personal history of anaphylaxis due to wheat-dependent exercise induced anaphylaxis, and/or
- Patients with celiac disease or diagnosis other than IgE-mediated wheat allergy (eg eosinophilic gastrointestinal diseases), and/or
- Patients with cardiovascular disease or other significant systemic disease, and/or
- Patients presenting severe anaphylactic reaction to very low doses of wheat (eg. after administration of the 1st or 2nd dose during the baseline OFC).
Key Trial Info
Start Date :
January 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 10 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03352193
Start Date
January 8 2018
End Date
October 10 2025
Last Update
July 30 2024
Active Locations (1)
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1
Department of Allergy and Clinical Immunology, 2nd Pediatric Clinic, General Children's Hospital P-A Kyriakou
Athens, Greece, 11527