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

NCT01332084 | Completed

• 1 other identifier: 09.19.INF
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Food Allergy

Keywords

SOTI; tolerance; desensitization; challenge test; HA wheat cereals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• assess allergic reactions to a challenge test to wheat

  6 months

Study Arms (1)

hypoallergenic wheat cereals

EXPERIMENTAL

HA wheat cereal used in a SOTI test

Other: HA wheat cereals

Interventions

HA wheat cereals OTHER

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

hypoallergenic wheat cereals

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (2)

Adult&Child Allergy Unit, HUG

Geneva, 1211, Switzerland

Location

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

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 8, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

CH (2)