Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand

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