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

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.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Other: HA 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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Adult&Child Allergy Unit, HUG
  • Lausanne, Switzerland, 1011
    • Unité d'immunologie, allergologie et rhumatologie pédiatrique Département médico-chirurgical de pédiatrie CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess allergic reactions to a challenge test to wheat	challenge test will be performed at the end of the treatment with HA cereals. Other blood immunological parameters will be evaluated.	6 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 21, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: tolerance; desensitization; challenge test; SOTI; HA wheat cereals
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 09.19.INF