High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety (NCT04415593) | Clinical Trial Compass
CompletedNot Applicable
High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
Poland44 participantsStarted 2020-09-01
Plain-language summary
In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.
Who can participate
Age range4 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* medical history of peanut allergy,
* IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut 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 less than 100 mg of peanut protein during OOFC,
* signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
* patient's/caregivers' cooperation with researcher.
Exclusion Criteria:
* no confirmed peanut allergy,
* negative oral food challenge with less than 100mg of peanut protein,
* 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, angio…
What they're measuring
1
Tolerance of peanuts
Timeframe: Up to 16 months after starting oral immunotherapy