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

Christina West275 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

275

Conditions

Allergy

Interventions

Elemental E028 with added food allergensOTHER

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

Elemental E028OTHER

Elemental E028 with no added food allergens

Eligibility

Sex: ALLMin age: 8 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Clinical Sciences, pediatrics

Umeå, Sweden

Outcomes

Primary Outcomes

Number of participants detecting sensorial differences between the active materials (containing the allergens cow's milk, hen's egg, soy, wheat or cod) and the placebo materials

The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by assessing that no sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials could be detected by test panels.

Data from ClinicalTrials.gov

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