Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
Recruiting now · Not applicable
Conditions studied: Food Allergy
In brief
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.
Key facts
- Study ID
- NCT06261554
- Run by
- Medical University of Warsaw
- People needed
- 39
- Starts
- 2024-03-14
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2024-05-20
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Medical University of Warsaw — Warsaw, Masovian Voivodeship, Poland (enrolling)
Full record on ClinicalTrials.gov
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