Allergy Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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