Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01332084
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2011-04-06
Brief Title:
Use of Hypoallergenic HA Cereals in Children With Diagnosed Allergy to Wheat
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
Study Overview
Official Title:
Assessment of the Feasibility of a SOTI With Hypoallergenic HA Cereals in Children With Diagnosed IgE-mediated Allergy to Wheat
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HA 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 HA wheat cereals have similar efficacy with less side effects than native wheat cereals
The investigators hypothesize that HA 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 HA cereals in children with diagnosed IgE-Mediated allergy to wheat
This is a multi centre open pilot study testing 1 product10 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
This is a multi centre open pilot study testing 1 product10 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None