preventcd
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
PreventCD
Zrinjka MišakReferral Centre for Paediatric Gastroenteorology
and NutritionChildren’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
Israel
PREVENT CD PARTNERS
PREVENT CD TASK FORCE
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
fatherand/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 disease3. 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 protocolENROLLMENT
Families with a CD patient
BIRTHHLA 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. Mearin2 on 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 802HLA DQ2/DQ8 positive 81HLA 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 – performed biopsies and confirmed diagnosis
Center Enrolled Biopsies Cases tTG AGA tTG+AGA Symptoms Atrophy
101-Netherlands 134 10 4 0 0 4 3 4
102-Italy 142 9 4 0 0 4 2 4
103-Poland 53 1 1 0 0 1 0 1
104-Madrid 78 5 3 0 0 3 2 3
105-Valencia 80 3 3 0 0 3 3 3
106-Israel 98 6 2 0 0 2 2 2
107-Croatia 8 0 0 0 0 0 0 0
108-Hungary 136 8 7 2 0 5 1 7
109-Catalonia 93 7 7 0 0 7 6 7
110-Germany 114 0 0 0 0 0 0 0
TOTAL 936 49 31 2 0 29 19 31
PreventCD
CD group (31) No CD group (18)
Median age (months) 26.1 21.4
Symptoms present 19 13
tTG 2 2
AGA-A + tTG 29 1
AGA-A 0 4
tTG median titre 88 3.3
AGA-A median titre 57.6 18.4
Villous Atrophy 31 2
CLINICAL, SEROLOGICAL AND HISTOLOGICAL FEATURES OF BIOPSIED PATIENTS WITH CONFIRMED CD AND NON-CD PATIENTS
PreventCD – cumulative incidence of CD in the PreventCD cohort
The cumulative incidence of CD in this high risk
cohort is about 6.6% at 3 years of age
31/936 => 3.3%
Codes are still not unblided.
PreventCD – cumulative incidence by HLA
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%)
% I
nci
den
ce HLA DQ2 homozygous will have an
incidence of 25% of cases versus the 1-5% in the lower
risk class.
PreventCD
1. 6.6% cumulative incidence at 3 years
2. Symptoms are not predictive
3. Anti-tTG antibodies, but not AGA, are very predictive
The Frequency Of Coeliac Disease (CD) In High Risk Young Children From Families
With CD: The PreventCD Cohort
Auricchio R, et al, 2011
Acknowledgements