Influence of the dietary history in the PREVENTion of Coeliac Disease: possibilities of induction of tolerance for gluten in genetic predisposed childre
Not Applicable
Completed
- Conditions
- Coeliac diseaseDigestive SystemIntestinal malabsorption
- Registration Number
- ISRCTN74582487
- Lead Sponsor
- eiden University Medical Centre (LUMC) (The Netherlands)
- Brief Summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25271603
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 944
Inclusion Criteria
1. Infant born during the study with a first degree relative (parent or sibling) with coeliac disease (CD)
2. Informed consent for the study
Exclusion Criteria
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 three years will be considered as an effective prevention.
- Secondary Outcome Measures
Name Time Method <br> 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>