Tolerance of Cereals for Atopic Children

NCT ID: NCT01029184

Last Updated: 2012-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-01-31

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.

Conditions

Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

complete non allergenic cereals

existing commercialized product

Group Type: ACTIVE_COMPARATOR

commercialized complete cereals

Intervention Type: OTHER

complete cereals suitable for the weaning period

complete non allergenic cereals plus

commercialised product with the addition of a novel ingredient

Group Type: EXPERIMENTAL

commercialized complete cereals with additional ingredient

Intervention Type: OTHER

complete cereals suitable for weaning period

Interventions

commercialized complete cereals

complete cereals suitable for the weaning period

Intervention Type: OTHER

commercialized complete cereals with additional ingredient

complete cereals suitable for weaning period

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach

Gaißach Bei Bad Tölz, , Germany

Countries

Germany

Other Identifiers

07.47.INF

Identifier Type: -

Identifier Source: org_study_id