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

Christina West

Status: Completed

Conditions: Allergy

Treatments: Other: Elemental E028 with added food allergens; Other: Elemental E028

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01633840

06-089M

Details and patient eligibility

About

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.

Enrollment: 275 patients

Sex: All

Ages: 8 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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275 participants in 2 patient groups, including a placebo group

Elemental E028 with added food allergens

Active Comparator group

Treatment:

Other: Elemental E028 with added food allergens

Elemental E028

Placebo Comparator group

Treatment:

Other: Elemental E028