Comparing high and low doses of sesame immunotherapy for children with sesame allergy
High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety
This study is testing if giving children with sesame allergies either a high or low dose of sesame protein can help them tolerate sesame better over 14 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT05158413 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and safety of oral immunotherapy using sesame protein in children aged 4 to 17 with confirmed sesame allergies. Participants will be randomized to receive either a high dose (1200 mg) or a low dose (300 mg) of sesame protein, with a gradual increase in dosage over a 14-month period. The study will assess desensitization through skin prick tests and oral food challenges, alongside blood tests for specific IgE and IgG4 levels. The aim is to determine the optimal dosing strategy for managing sesame allergies in children.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 17 years with a confirmed IgE-mediated sesame allergy.
Not a fit: Patients without a confirmed sesame allergy or those with severe asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that significantly reduces the severity of sesame allergies in children.
How similar studies have performed: Previous studies on oral immunotherapy for food allergies have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Warsaw
- Katarzyna Grzela — Warsaw, Poland (Recruiting)
Study contacts
- Study coordinator: Katarzyna Grzela, MD, PhD
- 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.