Low-dose sesame oral immunotherapy for children with sesame allergy
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients: A Randomized Controlled Trial
This study is testing if giving low doses of sesame protein can help children with sesame allergies tolerate more sesame in their diet compared to just avoiding it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT06261554 on ClinicalTrials.gov |
What this trial studies
This pilot study is a randomized controlled trial that evaluates the efficacy and safety of low-dose oral immunotherapy (OIT) using sesame protein in pediatric patients with confirmed sesame allergies. Participants aged 3 to 17 will be randomly assigned to receive either OIT with a maintenance dose of 300mg sesame protein or standard treatment involving a restrictive elimination diet. The primary outcome measures the proportion of participants who can tolerate a single dose of 4000mg sesame protein during a final oral food challenge, while secondary outcomes include monitoring adverse events and changes in immunological parameters over an 18-month period.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 17 years with confirmed IgE-mediated sesame allergy.
Not a fit: Patients without a confirmed sesame allergy or those who have had a negative oral food challenge with sesame protein will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for children with sesame allergies by increasing their tolerance to sesame protein.
How similar studies have performed: While oral immunotherapy has shown promise in treating other food allergies, this specific approach to sesame allergy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Warsaw, Masovian Voivodeship
- Medical University of Warsaw — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Katarzyna Grzela, PhD, MD
- Email: katarzyna.grzela@wum.edu.pl
- Phone: +48 22 3179431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.