Tolerance of Cereals for Atopic Children

Nestlé

Status

Terminated

Conditions

Allergy

Treatments

Other: commercialized complete cereals

Other: commercialized complete cereals with additional ingredient

Study type

Interventional

Funder types

Industry

Identifiers

NCT01029184

07.47.INF

Details and patient eligibility

About

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

Full 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.

Enrollment

45 patients

Sex

All

Ages

4 months to 4 years old

Volunteers

No 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