NCT01029184

Tolerance of Cereals for Atopic Children

Assessment of Tolerance of Cereals in Infants With Atopic Symptoms

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 4 Months – 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergy

Interventions

Type	Name	Description
OTHER	commercialized complete cereals	complete cereals suitable for the weaning period
OTHER	commercialized complete cereals with additional ingredient	complete cereals suitable for weaning period

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2009-12-09
• Last updated: 2012-06-27

Locations

1 site across 1 country: Germany