NCT01332084

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Food Allergy

Interventions

Type	Name	Description
OTHER	HA wheat cereals	HA wheat cereals used in SOTI test and as part of desensitization plan

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-04-08
• Last updated: 2012-06-22

Locations

2 sites across 1 country: Switzerland