NCT06261554 Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
| NCT ID | NCT06261554 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Warsaw |
| Condition | Food Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 39 participants in total. It began in 2024-03-14 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06261554 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06261554 currently recruiting?
Yes, NCT06261554 is actively recruiting participants. Contact the research team at katarzyna.grzela@wum.edu.pl for enrollment information.
Where is the NCT06261554 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06261554 clinical trial?
NCT06261554 is sponsored by Medical University of Warsaw. The trial plans to enroll 39 participants.