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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02046083). StuddyBuddy aggregates publicly available trial information.