Clinical trial NCT01332084: Use of Hypoallergenic (H.A.) Cereals in Children With Diagnosed Allergy to Wheat
Official title: Assessment of the Feasibility of a SOTI With Hypoallergenic (H.A.) Cereals in Children With Diagnosed IgE-mediated Allergy to Wheat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Keywords: SOTI
tolerance
desensitization
challenge test
HA wheat cereals
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 9
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Infant of any ethnicity aged between 1 to 12 years old at the time of enrollment and
* Positive Skin Prick Test (SPT) to wheat and/or Positive specific IgE to wheat and
* Immediate positive reaction (IgE-type reaction) to wheat as shown by provocation test done a maximum 1 year before the enrollment to the study or an unambiguous history for wheat allergy as evaluated by the investigator and
* Having obtained his/her signed legal representative's informed consent

Exclusion Criteria:

* Child on systemic drugs (potentially affecting the allergic reactions e.g. antihistamines) according to half-life at time of enrollment or
* Congenital illness or malformation that may affect normal growth (especially immunodeficiency) or
* Child with uncontrolled asthma or
* Child whose parents/caregivers cannot be expected to comply with treatment or
* Child currently participating in another interventional clinical trial.

Primary outcomes:
measure: Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat
timeFrame: 6 months
Secondary outcomes:
measure: assess allergic reactions to a challenge test to wheat
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Adult&Child Allergy Unit, HUG
city: Lausanne
country: Switzerland
facility: Unité d'immunologie, allergologie et rhumatologie pédiatrique Département médico-chirurgical de pédiatrie CHUV
Study officials:
affiliation: Universitäts-Kinderklinik Zürich
name: Roger Lauener, Prof MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Département médico-chirurgical de pédiatrie, CHUV, Lausanne
name: Jacqueline Wassenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adult&Child Allergy Unit, Geneva
name: Philippe Eigenmann, MD
role: PRINCIPAL_INVESTIGATOR
References: