Use of Hypoallergenic (H.A.) Cereals in Children With Diagnosed Allergy to Wheat

NCT ID: NCT01332084

Last Updated: 2012-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-02-29

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.

Conditions

Food Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hypoallergenic wheat cereals

HA wheat cereal used in a SOTI test

Group Type: EXPERIMENTAL

HA wheat cereals

Intervention Type: OTHER

HA wheat cereals used in SOTI test and as part of desensitization plan

Interventions

HA wheat cereals

HA wheat cereals used in SOTI test and as part of desensitization plan

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Lauener, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Kinderklinik Zürich

Jacqueline Wassenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Département médico-chirurgical de pédiatrie, CHUV, Lausanne

Philippe Eigenmann, MD

Role: PRINCIPAL_INVESTIGATOR

Adult&Child Allergy Unit, Geneva

Locations

Adult&Child Allergy Unit, HUG

Geneva, , Switzerland

Unité d'immunologie, allergologie et rhumatologie pédiatrique Département médico-chirurgical de pédiatrie CHUV

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

09.19.INF

Identifier Type: -

Identifier Source: org_study_id