Efficacy of Cashew Nut Protein Immunotherapy
ConditionFood Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorMedical University of Warsaw
About this trial
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.
Eligibility criteria
Qualifiers
age between 4 and 17 years,
IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and/or specific IgE (immunoglobulin E) level greater than 0.35-kilo units of Allergen per liter (kUA/l),
allergic reaction to cashew protein during oral food challenge (OFC),
Signed Informed Consent by parent/legal guardian and patient aged >16 years old,
Disqualifiers
no confirmed allergy to cashew,
negative provocation test with cashew,
severe asthma,
mild/moderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) <80% (less than 5 perc), FEV1/FVC (forced expiratory volume at one second/forced vital capacity) <75% (less than 5 perc), hospitalization for asthma exacerbation in the past 12 months,
Trial design
Treatments tested in this trial
- Cashew immunotherapy
Treatment groups
39 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov