New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges

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

COMPLETED

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-12-31

Brief Summary

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This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be used in blinded low-dose food challenges.

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Detailed Description

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Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Elemental E028 with added food allergens

Group Type ACTIVE_COMPARATOR

Elemental E028 with added food allergens

Intervention Type OTHER

Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)

Elemental E028

Group Type PLACEBO_COMPARATOR

Elemental E028

Intervention Type OTHER

Elemental E028 with no added food allergens

Interventions

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Elemental E028 with added food allergens

Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)

Intervention Type OTHER

Elemental E028

Elemental E028 with no added food allergens

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children belonging to one of two age groups: 7-8 years or 14-15 years
* No previous hypersensitivity reaction to the food to be tested
* Capacity to understand the test instructions and to participate in the test sessions

Exclusion Criteria

* Children not belonging to one of the two age groups: 7-8 years or 14-15 years
* One or more previous hypersensitivity reaction to the food to be tested
* Unability to understand the test instructions and to participate in the test sessions

Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes