Peanut Allergy
Conditions
Keywords
Teenager, Peanut, OIT (Oral Induction Tolerance)
Brief 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
Detailed description
Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance
Interventions
DRUGarachid
OTHERPlacebo
Placebo
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients which tolerate the cumulative dose of 2 grams of peanut at the end of the first phase of 24 weeks between treatment and placebo groups | at 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase | at 24 weeks |
| Percentage of patients with adverse effects during induction phase | at 24 weeks |
| Modifications of the immune profile showing a desensitization to peanut | at 24 weeks |
| Percentage of patients which tolerate the cumulative dose of 2 grams of peanut during a Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) after 24 weeks without traces eviction diet after the end of maintenance phase | at 24 weeks |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean-Luc FAUQUERT
University Hospital, Clermont-Ferrand
Outcome results
None listed