Master Allergen Child Nutrition. Reintroduction of Small Doses

NCT ID: NCT02384707

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-12-31

Brief Summary

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Reintroduction of small doses of food in allergic children to lightening the elimination diet.

Detailed Description

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In four groups of allergic children (peanuts, wheat , milk and egg), a reintroduction of 4 small increasing doses of allergen is carried out progressively double-blind placebo- cons , randomized, during a hospitalization.

The procedure for reintroduction of small doses (MPD) is stopped at the appearance of intolerance (in taking a dose of allergen or placebo) defined by the onset of allergic symptoms or objective severe abdominal pain within 45 minutes of taking.

Conditions

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Food Allergies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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allergic food

Reintroduction procedure for small doses :

* Administration of the first dose the first dose must be allergic food or placebo
* Clinical monitoring for 45 minutes
* Administration of the second dose

Group Type EXPERIMENTAL

allegic food

Intervention Type OTHER

Reintroduction procedure for small doses :

* Administration of the first dose
* Clinical monitoring for 45 minutes
* Administration of the second dose

Placebo

Intervention Type OTHER

Interventions

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allegic food

Reintroduction procedure for small doses :

* Administration of the first dose
* Clinical monitoring for 45 minutes
* Administration of the second dose

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Allergic children 1 and 16 years for peanut, egg and wheat. So, for milk between 9 months and 16 years.
* Accurate diagnostic
* Allergic react rapidly and acute

Exclusion Criteria

* severe disease
Minimum Eligible Age

9 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine Drouet

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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Denise Jolivot

Angers, Pays de Loire, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Martine Drouet

Role: CONTACT

Facility Contacts

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MARTINE DROUET, PH

Role: primary

33241354541

Other Identifiers

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2010-A00448-31

Identifier Type: -

Identifier Source: org_study_id

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