Actively Recruiting
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
Led by Medical University of Warsaw · Updated on 2024-05-20
39
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and 17 years
- Confirmed IgE-mediated sesame allergy by positive skin prick test or specific IgE above 0.35 kUA/l
- Allergic reaction to sesame protein during oral food challenge
- Signed informed consent by parent/legal guardian and patient if older than 16 years
- Cooperation of patient and caregivers with the researcher
You will not qualify if you...
- No confirmed sesame allergy
- Negative oral food challenge with sesame protein up to 4000 mg
- Severe asthma or uncontrolled mild/moderate asthma with specific lung function criteria or recent hospitalization
- Current oral, sublingual, or subcutaneous immunotherapy with other allergens within first year
- Eosinophilic gastroenteritis
- History of severe recurrent anaphylaxis episodes
- Chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes
- Recent or ongoing oral steroid therapy or biological treatment
- Use of beta-blockers, ACE inhibitors, or calcium channel blockers
- Pregnancy
- Lack of consent to participate
- Lack of cooperation by patient or caregiver
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland, 02-091
Actively Recruiting
Research Team
K
Katarzyna Grzela, PhD, MD
CONTACT
J
Joanna Zielińska, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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