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Tolerance of Cereals for Atopic Children

Primary Purpose

Allergy

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
commercialized complete cereals
commercialized complete cereals with additional ingredient
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring weaning, cereals, allergy, atopy, open allergenic test

Eligibility Criteria

4 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

complete non allergenic cereals

complete non allergenic cereals plus

Arm Description

existing commercialized product

commercialised product with the addition of a novel ingredient

Outcomes

Primary Outcome Measures

Documentation of atopic symptoms and clinical examination for presence or absence of some objective and subjective symptoms with evaluation of severity (SCORAD) if necessary

Secondary Outcome Measures

Morbidity will be assessed by the frequency of adverse events

Full Information

First Posted
December 8, 2009
Last Updated
June 26, 2012
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01029184
Brief Title
Tolerance of Cereals for Atopic Children
Official Title
Assessment of Tolerance of Cereals in Infants With Atopic Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
difficult to enrol and as a pilot study sample size was not powered anyway
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
weaning, cereals, allergy, atopy, open allergenic test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
complete non allergenic cereals
Arm Type
Active Comparator
Arm Description
existing commercialized product
Arm Title
complete non allergenic cereals plus
Arm Type
Experimental
Arm Description
commercialised product with the addition of a novel ingredient
Intervention Type
Other
Intervention Name(s)
commercialized complete cereals
Intervention Description
complete cereals suitable for the weaning period
Intervention Type
Other
Intervention Name(s)
commercialized complete cereals with additional ingredient
Intervention Description
complete cereals suitable for weaning period
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Morbidity will be assessed by the frequency of adverse events
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach
City
Gaißach bei Bad Tölz
ZIP/Postal Code
83674
Country
Germany

12. IPD Sharing Statement

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Tolerance of Cereals for Atopic Children

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