Tolerance of Cereals for Atopic Children

June 26, 2012 updated by: Nestlé

Assessment of Tolerance of Cereals in Infants With Atopic Symptoms

In this study, non allergenic cereals will be tested in infants with atopic symptoms. The test will be performed in a hospital.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In the majority of food allergy cases, an exclusion diet results in regression of clinical symptoms but this diet may not be nutritionally complete. To feed a baby who has a food allergy, we want a food with low allergenic ingredients.

For this reason, a complete cereal has been specially developed and formulated for the weaning period of infants and young children suffering from milk, soy or wheat protein allergy or hypersensitivity due to celiac disease.

It allows a smooth transition into and through the weaning period. The ingredients of this product are all from vegetable sources and it is therefore suitable for a vegetarian diet. It has been commercialised for many years and has proved to be completely safe, however so far no study has been specifically designed and powered to assess tolerance of this product in infants with atopic symptoms.

In this study we are testing the tolerance (symptoms stability) of non allergenic cereals during an open allergenic test in infants with atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test. We are also testing the same product containing an additional ingredient with a potential effect in allergy management.

Such complete cereals is a very good option for allergic children in comparison to an exclusion diet that may not be nutritionally complete.

Study Type

Interventional

Enrollment (Actual)

45

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

  • Germany
      • Gaißach bei Bad Tölz, Germany, 83674
        • Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach

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

4 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infant aged from 4 to 40 months at the time of enrolment
  • With atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test
  • Infants who received a specific elimination oligoallergenic diet from the study site for at least 5 days before the day of enrolment
  • Having obtained his/her signed legal representative's informed consent

Exclusion Criteria:

  • Infant on systemic drugs (e.g. antihistamines) according to half-life at time of enrolment
  • Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
  • Infant whose parents / caregivers cannot be expected to comply with treatment.
  • Infant currently participating in another interventional clinical trial

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: complete non allergenic cereals
existing commercialized product
Other: commercialized complete cereals
complete cereals suitable for the weaning period
Experimental: complete non allergenic cereals plus
commercialised product with the addition of a novel ingredient
Other: commercialized complete cereals with additional ingredient
complete cereals suitable for weaning period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Documentation of atopic symptoms and clinical examination for presence or absence of some objective and subjective symptoms with evaluation of severity (SCORAD) if necessary
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity will be assessed by the frequency of adverse events
Time Frame: 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

Nestlé

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

February 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.47.INF

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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