Clinical trial NCT02046083: Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers
Official title: Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Peanut Allergy
Keywords: Teenager
Peanut
OIT (Oral Induction Tolerance)
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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
timeFrame: at 24 weeks
Secondary outcomes:
measure: Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase
timeFrame: at 24 weeks
measure: Percentage of patients with adverse effects during induction phase
timeFrame: at 24 weeks
measure: Modifications of the immune profile showing a desensitization to peanut
timeFrame: at 24 weeks
measure: 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
timeFrame: at 24 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Luc FAUQUERT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michaud E, Evrard B, Pereira B, Rochette E, Bernard L, Rouzaire PO, Gourdon-Dubois N, Merlin E, Fauquert JL. Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial. Trials. 2015 Apr 29;16:197. doi: 10.1186/s13063-015-0717-y.