High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety

Launched by MEDICAL UNIVERSITY OF WARSAW · Dec 14, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating how effective and safe it is to use oral sesame immunotherapy in children with sesame allergies. Researchers are comparing two different doses of sesame protein: a lower dose of 300mg and a higher dose of 1200mg. The goal is to see which dose works better for helping children with this type of food allergy.

To be eligible for the trial, children must have a confirmed sesame allergy and show a reaction to sesame during a specific test. Participants should be between 4 and 17 years old, and a parent or guardian must give permission for them to join. Throughout the study, participants will receive sesame protein to help their bodies get used to it, and the researchers will closely monitor their health and any reactions. It’s important for potential participants to be aware that certain medical conditions and treatments may disqualify them from joining, so discussing this with a healthcare provider is crucial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • medical history of sesame allergy,
• • IgE-mediated sesame allergy confirmed as positive skin prick tests with sesame allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method),
• • reaction to sesame protein during OOFC (maximum dose 4000g),
• • signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
• • patient's/caregivers' cooperation with researcher.
• Exclusion Criteria:
• • no confirmed sesame allergy,
• • negative oral food challenge with sesame protein (maximum dose 4000g),
• • severe asthma,
• • uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5. percentile), FEV1/forced vital capacity (FVC)\<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months,
• • current oral/sublingual/subcutaneous immunotherapy with other allergen,
• • eosinophilic gastroenteritis,
• • a history of severe recurrent anaphylaxis episodes,
• • chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
• * medication:
• • oral, daily steroid therapy longer than 1 month within last 12 months,
• • at least two courses of oral steroid therapy (at least 7 days) within last 12 months,
• • oral steroid therapy longer than 7 days within last 3 months,
• • biological treatment,
• • the need to constantly take antihistamines,
• • therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors,
• • pregnancy,
• • no consent to participate in the study,
• • lack of patient cooperation.