Ignite Creation Date:
2024-05-05 @ 9:04 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00808301
Status:
UNKNOWN
Last Update Posted:
2015-03-18
First Post:
2008-12-12
Brief Title:
Oat Products in the Treatment of Coeliac Disease in Children
Sponsor:
Heinz Italia SpA
Organization:
Heinz Italia SpA
Study Overview
Official Title:
Multicentre Clinical Trial on Oat Products in the Treatment of Coeliac Disease in Children
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety not contaminated with gluten in a sample of Italian celiac patients in pediatric age
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety not contaminated with gluten in a sample of Italian celiac patients in pediatric age
Detailed Description:
Several clinical trials have demonstrated that most celiac patients both of pediatric and of adult age can take medium-high quantity of oat 50-100 gday without any negative clinical effects
In a small number of cases intestinal dyspeptic disorders especially meteorism can be observed particularly during the first weeks of oat intake They are generally without clinical significance because they are a consequence of the increased fibre intake
There are only few cases of true oats intolerance The addition of oat improves the nutritional quality of the gluten-free diet particularly due to the increased intake of fibre and some oligoelements iron zinc tiamin pholates and expands the spectrum of food choices
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years
For the oat-based product to be considered suitable in the dieto-therapy of coeliac disease the absence of gluten contamination and possibly the origin from a variety of oat which is without traces of gluten cross-reactive peptides must be guaranteed
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety not contaminated with gluten in a sample of Italian celiac patients in pediatric age
In a small number of cases intestinal dyspeptic disorders especially meteorism can be observed particularly during the first weeks of oat intake They are generally without clinical significance because they are a consequence of the increased fibre intake
There are only few cases of true oats intolerance The addition of oat improves the nutritional quality of the gluten-free diet particularly due to the increased intake of fibre and some oligoelements iron zinc tiamin pholates and expands the spectrum of food choices
In many Northern European countries oat-based products have been used in the dieto-therapy of coeliac disease for many years
For the oat-based product to be considered suitable in the dieto-therapy of coeliac disease the absence of gluten contamination and possibly the origin from a variety of oat which is without traces of gluten cross-reactive peptides must be guaranteed
The purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety not contaminated with gluten in a sample of Italian celiac patients in pediatric age
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