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

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.

Completed

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Key information

Conditions

Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Sciences, pediatrics

Umeå, 901 87, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elemental E028 with added food allergens

Other

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

Elemental E028

Other

Elemental E028 with no added food allergens

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.

Sponsors and collaborators

Lead sponsor

Christina West

Other

Collaborators

Nutricia, Inc.
Oskarsfonden
State Government founding for Health Care research
The Västerbotten county council

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jul 4, 2012
Registry last updated: Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed