Tolerance of Cereals for Atopic Children

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

Detailed Description
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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.

Official Title
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Assessment of Tolerance of Cereals in Infants With Atopic Symptoms

Conditions
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Allergy

Intervention / Treatment
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* Other: commercialized complete cereals
* Other: commercialized complete cereals with additional ingredient


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 48 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weaning, cereals, allergy, atopy, open allergenic test