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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332084
• Other study ID #: 09.19.INF
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: June 21, 2012
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Wheat Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Switzerland	Adult&Child Allergy Unit, HUG	Geneva
Switzerland	Unité d'immunologie, allergologie et rhumatologie pédiatrique Département médico-chirurgical de pédiatrie CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes