Low-dose sesame oral immunotherapy for children with sesame allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.