Food Allergy Clinical Trial
Official title:
Assessment of the Feasibility of a SOTI With Hypoallergenic (H.A.) Cereals in Children With Diagnosed IgE-mediated 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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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