Use of Hypoallergenic (H.A.) Cereals in Children With Diagnosed Allergy to Wheat
The investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for children with allergy to wheat. The study has the potential to offer a desensitization treatment option for children allergic to wheat.
The investigators hypothesize that H.A. wheat cereals have similar efficacy with less side effects than native wheat cereals.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of the Feasibility of a SOTI With Hypoallergenic (H.A.) Cereals in Children With Diagnosed IgE-mediated Allergy to Wheat|
- Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The primary outcome is to document Clinical examination for presence or absence of immediate adverse reaction during the SOTI with evaluation of the maximum dose tolerated during the SOTI.
Symptoms related to allergic reactions during the SOTI (if applicable)will be recorded in the CRF.
- assess allergic reactions to a challenge test to wheat [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]challenge test will be performed at the end of the treatment with HA cereals. Other blood immunological parameters will be evaluated.
|Study Start Date:||April 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: hypoallergenic wheat cereals
HA wheat cereal used in a SOTI test
Other: HA wheat cereals
HA wheat cereals used in SOTI test and as part of desensitization plan
In this pilot study, the investigators aim to assess the feasibility of a SOTI (Specific Oral Tolerance Induction) with hypoallergenic (H.A.) cereals in children with diagnosed IgE-Mediated allergy to wheat.
This is a multi centre, open, pilot study testing 1 product.10 children of any ethnicity aged from 1 to 12 years old with diagnosed allergy to wheat will be eligible to participate in the study. The duration of the treatment will be 6 months with a minimum of 1 month of daily consumption of the hydrolyzed wheat cereals.
Each subject will feed with a quantity of the assigned study product according to the SOTI. The SOTI will be performed at the hospital under the control of qualified doctors and nurses.
The study product is administered starting with very low dosages, which are increased stepwise every 30 minutes up to an amount equivalent to the usual daily oral intake. Thereafter, the study product corresponding to the maximum dose tolerated is given in a maintenance dose in one serve every day until the final visit during which a challenge test with wheat will be performed to assess the tolerance of whole wheat.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332084
|Adult&Child Allergy Unit, HUG|
|Geneva, Switzerland, 1211|
|Unité d'immunologie, allergologie et rhumatologie pédiatrique Département médico-chirurgical de pédiatrie CHUV|
|Lausanne, Switzerland, 1011|
|Principal Investigator:||Roger Lauener, Prof MD||Universitäts-Kinderklinik Zürich|
|Principal Investigator:||Jacqueline Wassenberg, MD||Département médico-chirurgical de pédiatrie, CHUV, Lausanne|
|Principal Investigator:||Philippe Eigenmann, MD||Adult&Child Allergy Unit, Geneva|