Influence of the dietary history in the prevention of coeliac disease: possibilities of induction of tolerance for gluten in genetic predisposed children.
- Conditions
- coeliac disease (coeliakie)glutenprevention (prevensie)breastfeeding (borstvoeding)early feeding (baby voeding)genetic predisposition (genetisch predispositie)HLAfood intervention (voedings interventie)prospective (prospectief)double blind
- Registration Number
- NL-OMON27354
- Lead Sponsor
- -
- Brief Summary
Statistical Analysis Plan, 74582487, August 1st, 2013, Prof.dr.H. Putter, Dr. M. L. Mearin, Sabine Vriezinga<br> http://preventcd.com/images/stories/Publications/PreventCD_SAP_1_0.pdf
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1000
1.Infant born during the study with a first degree relative (parent or sibling) with CD;
2.Informed consent for the study.
1. No informed consent;
2. Parents-guardians unable to understand the information necessary to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A reduction of 50% of CD among the intervention group at the age of 3 years will be considered as an effective prevention.<br>
- Secondary Outcome Measures
Name Time Method If the proposed early dietary intervention results in effective prevention of CD: <br>1. Development of new European guidelines for early nutrition in order to prevent the disease;<br>2. Identification of the influence of early feeding on the development of coeliac disease in relation with immunological and genetical factors.<br><br><br>
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