Tolerance of Cereals for Atopic Children
|ClinicalTrials.gov Identifier: NCT01029184|
Recruitment Status : Terminated (difficult to enrol and as a pilot study sample size was not powered anyway)
First Posted : December 9, 2009
Last Update Posted : June 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Allergy||Other: commercialized complete cereals Other: commercialized complete cereals with additional ingredient||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Tolerance of Cereals in Infants With Atopic Symptoms|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
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
- 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 ]
- Morbidity will be assessed by the frequency of adverse events [ Time Frame: 48 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029184
|Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach|
|Gaißach bei Bad Tölz, Germany, 83674|