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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

April 6, 2011
June 21, 2012
April 2011
February 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01332084 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Food Allergy
Other: HA wheat cereals
HA wheat cereals used in SOTI test and as part of desensitization plan
Experimental: hypoallergenic wheat cereals
HA wheat cereal used in a SOTI test
Intervention: Other: HA wheat cereals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
1 Year to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01332084
09.19.INF
No
Nestlé
Nestlé
Not Provided
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
Nestlé
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP