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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01332084
First received: April 6, 2011
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Food Allergy
 Other: HA wheat cereals

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Feasibility of a SOTI With Hypoallergenic (H.A.) Cereals in Children With Diagnosed IgE-mediated Allergy to Wheat

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • assess allergic reactions to a challenge test to wheat [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    challenge test will be performed at the end of the treatment with HA cereals. Other blood immunological parameters will be evaluated.


Enrollment: 9
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332084

Locations
Switzerland
Adult&Child Allergy Unit, HUG
Geneva, Switzerland, 1211
Unité d'immunologie, allergologie et rhumatologie pédiatrique Département médico-chirurgical de pédiatrie CHUV
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Nestlé
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
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01332084     History of Changes
Other Study ID Numbers: 09.19.INF
Study First Received: April 6, 2011
Last Updated: June 21, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Nestlé:
SOTI
tolerance
desensitization
challenge test
HA wheat cereals

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Wheat Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 22, 2013