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

April 27, 2021 updated by: Christina West
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, 901 87
        • Department of Clinical Sciences, pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Elemental E028 with added food allergens
Other: Elemental E028 with added food allergens
Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
Placebo Comparator: Elemental E028
Other: Elemental E028
Elemental E028 with no added food allergens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christina West

Collaborators

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

Investigators

  • Principal Investigator: Christina E West, MD, PhD, Umeå University Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 29, 2012

First Posted (Estimate)

July 4, 2012

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-089M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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