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Completed
NCT02046083
Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers
Conditions: Peanut Allergy
Sex: All
Ages: 12 Years – 18 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 60
Sponsor: University Hospital, Clermont-Ferrand
Location: CHU Clermont-Ferrand Clermont-Ferrand
Summary
The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the interest of a prolonged maintenance therapy
Eligibility Criteria
Inclusion Criteria:
* Adolescents between 12 and 18 years
* Clinical History of allergic manifestation within one hour of ingestion of peanuts or Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) peanut positive below the threshold of 2 grams
* Bad reaction peanut demonstrated by positive Patch Test (PT ≥ 3 mm above the negative control) and specific IgE f13\> 12 IU / mL and / or rAra h2\> 5.8 IU / mL
* Previous follow at least 1 year
Exclusion Criteria:
* Lack of response during the initial DBPCFCs to the cumulative dose of 2 grams of peanut or instant dose of 1 gram of peanut
* Uncontrolled asthma and / or severe over the previous year
* Atopic dermatitis uncontrolled
* Initial severe anaphylaxis requiring hospitalization in intensive care
* Presence of a major allergy with anaphylaxis at another allergen risk (milk, egg, nuts, or other)
* Home away from a center could support a severe reaction in emergency
* Lack of motivation and understanding of parents and / or child
* Incapacity
* to establish a daily logbook of clinical monitoring
* to support severe reaction after eating peanut
* to follow a regular peanut ingestion protocol
Source: ClinicalTrials.gov (NCT02046083). StuddyBuddy aggregates publicly available trial information.