Clinical trial NCT01029184: Tolerance of Cereals for Atopic Children
Official title: Assessment of Tolerance of Cereals in Infants With Atopic Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Allergy
Keywords: weaning
cereals
allergy
atopy
open allergenic test
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Documentation of atopic symptoms and clinical examination for presence or absence of some objective and subjective symptoms with evaluation of severity (SCORAD) if necessary
timeFrame: 48 hours
Secondary outcomes:
measure: Morbidity will be assessed by the frequency of adverse events
timeFrame: 48 hours
Other outcomes:
Locations:
city: Gaißach bei Bad Tölz
country: Germany
facility: Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach
Study officials:
References: