RecruitingNot ApplicableNCT06261554

Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients

Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients: A Randomized Controlled Trial

Sponsor

Medical University of Warsaw

Enrollment

39 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

Food allergy

Summary

It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.

Eligibility

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria5

Age between 3 and 17 years,
IgE-mediated sesame allergy confirmed with 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),
Allergic reaction to sesame protein during oral food challenge (OFC),
Signed Informed Consent by parent/legal guardian and patient aged >16 years old,
Patient's and caregivers' cooperation with the researcher.

Exclusion Criteria16

No confirmed sesame allergy,
Negative OFC with sesame protein (maximum dose 4000mg),
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 allergens in the first year of immunotherapy,
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 the last 12 months,
at least two courses of oral steroid therapy (at least 7 days) within the last 12 months,
oral steroid therapy longer than 7 days within the last 3 months,
any biological treatment,
therapy with β-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors,
Pregnancy,
No consent to participate in the study,
Lack of patient or caregiver cooperation.

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Interventions

DIETARY_SUPPLEMENTDietary Supplement: Low dose OIT

Following the building-up phase (up to 14 months), patients will receive a daily low dose of sesame paste (300 mg sesame protein) mixed with well-tolerated fruit mousse or bread for 3 months (12 +/- 3 weeks).