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PreventCD. Zrinjka Mišak Referral Centre for Paediatric Gastroenteorology and Nutrition Children’s Hospital Zagreb, Croatia. PreventCD – ‘to prevent coeliac disease’. multicenter European project s pons o red by the 6th frame program of the EU performed by 16 centers in
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PreventCD Zrinjka Mišak Referral Centre for Paediatric Gastroenteorology and Nutrition Children’s Hospital Zagreb, Croatia
PreventCD– ‘to prevent coeliac disease’ • multicenter European project • sponsored by the 6th frame program of the EU • performed by 16 centers in 10 European countries + AOECS • Project leader: Luisa Mearin Leiden, The Netherlands
PREVENT CD TASK FORCE Israel PREVENT CD PARTNERS
PreventCD– ‘to prevent coeliac disease’ Start 2007 the project studied the influence of the dietary history in the prevention of CD the idea was - if gradually small amounts of food substances were administered – the immune system would ‘learn’ not to respond to this substance
PreventCD • Hypothesis: The introduction of small amounts of gluten at the 5th and 6th months of age while still breast feeding will reduce the number of CD by 50%.
PreventCD – inclusion criteria • a total of 1000 newborns with higher risk of CD included and followed up to 3 years of age • Randomized double blind intervention study
PreventCD – inclusion criteria Children at risk for CD: CD diagnosed by intestinal biopsy in mother and/or father and/or sibling (1° relatives)
PreventCD – aims of the project 1. to enrolle a cohort at risk of developing CD and to follow it prospectively up to 3 years of age 2. to study the natural history of the disease 3. to prevent CD by giving small amount of gluten (100 mg) from the 4th to the 6th month of life during breast feeding according to a randomised double blind protocol
PreventCD – objective • is to significantly reduce the number of people suffering from CD in Europe, by developing primary prevention strategies for CD • if the proposed early dietary intervention results in effective prevention of CD => new European guidelines for early nutrition
PreventCD – project protocol ENROLLMENT Familieswith a CDpatient BIRTH HLA analysis (cord blood) HLA DQ2 and/orDQ8 positive HLA DQ2 and DQ8 negative • Encouragement of breast feeding • Intervention 4-6 mo (100 mg gliadin/day or placebo) • Gradual introduction of gluten at 6 months • Clinical and serological (AGAA-TGA) examination every 3-6 months Clinical and serological (AGAA-TGA) examination at 3 y
The Frequency of Coeliac Disease (CD) in High Risk Young Children from Families with CD: The PreventCD Cohort R. Auricchio1, C. E. Hogen Esch2, G. Castillejo3, E. Mummert 4, E. Bravi 5, I. Korponay-Szabo6, S. Koletzko 7, L. Greco 1, R. Troncone 1, M. L. Mearin2on behalf of Prevent CD Study Group 1Department of Pediatrics, University Federico II, Naples, Italy, 2Department of Pediatric Gastroenterology, University Medical Center, Leiden, Netherlands, 3Pediatrics Department, Hospital Universitari de Sant Joan de Reus , Reus, Spain, 4Phadia, Friburg, Germany, 5Eurospital, Trieste, Italy, 6Department of Paediatrics, Medical and Health Science Centre , University of Debrecen, Debrecen, Hungary, 7 Kinderspital, , Ludwig Maximilians University, Munich, Germany
PreventCD- HLA status of the cohort 1345 total number of children recruited 986 (73%) HLA DQ positive: HLA DQ2 positive 802 HLA DQ2/DQ8 positive 81 HLA DQ8 positive 103
PreventCD – progression of the PreventCD cohort More than half of children older than 2 years
PreventCD - breastfeeding >60% of children are still BF at 6 months of age Cumulative percentage of children who stopped breastfeeding
PreventCD – criteria for biopsy Symptoms ± 2 consecutive positive a-tTG tests or 3 times AGA-A positive Biopsy
PreventCD CLINICAL, SEROLOGICAL AND HISTOLOGICAL FEATURES OF BIOPSIEDPATIENTS WITH CONFIRMED CD AND NON-CD PATIENTS
PreventCD – cumulative incidence of CD in the PreventCD cohort 31/936 => 3.3% The cumulative incidence of CD in this high risk cohort is about6.6% at 3 years of age Codes are still not unblided.
PreventCD – cumulative incidence by HLA HLA DQ2 homozygous will have an incidence of 25% of cases versus the 1-5% in the lower risk class. % Incidence Exceptional risk: 0% Very low/low risk: 1.6% (1.6%) Medium risk (blue narrow): 4.3% (SE=1.3%) High risk (red narrow): 25.6% (SE=6.7%)
The Frequency Of Coeliac Disease (CD) In High Risk Young Children From Families With CD: The PreventCD Cohort PreventCD Auricchio R, et al, 2011 1. 6.6% cumulative incidence at 3 years 2. Symptoms are not predictive 3. Anti-tTG antibodies, but not AGA, are very predictive