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Role of child and parents |
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If you decide to participate in this study we will ask you the following things:
To determine if your child has a possible higher risk for developing coeliac disease a DNA-test will be done. Right after birth some cord blood will be collected. This is completely painless. To do so the baby does not need to be born in the LUMC; the cord blood may be collected anywhere else.
If your baby does not have a high risk to develop coeliac disease, the study will be ended.
All babies who do have a high risk of developing coeliac disease will be double blind divided in two groups. This means that neither you nor the researcher knows to which group your baby belongs. The "toleration test group" will get a small amount of gluten during the period of breastfeeding from the age of 4 months. The "fake test group" (control group) will get milk sugar powder during the period of breastfeeding from the age of 4 months. The milk sugar powder batch will appear exactly the same as gluten. This is done to perform the test as fair as possible.
Both groups will be followed during the period of 1 to 3 years.
If your child appears to have antibodies for coeliac disease (indicative of active coeliac disease), your child will be offered a small intestinal biopsy. This will be done during a one-day-admission in the Leiden University Medical Centre. The biopsy will be done making use of an anaesthetic. This is an invasive procedure, but nowadays the normal procedure in non-study-circumstances for such children with blood samples indicating active coeliac disease, would also perform an intestinal biopsy. So to participate or not to participate to this study will not be of any influence to this.
What will be asked from the mother?
You will be encouraged to breastfeed your child during a period of at least six months. If this is not possible for any reason whatsoever, you can still participate in the study.
Seven times you will be asked to collect a small amount of breast milk. |
With these samples we are able to analyse how many gluten the baby ingests by breastfeeding.
Of course we will help you with sending the samples.
We consider this study as successful if in at least half of the predicted cases in the "toleration test group" the development of coeliac disease has been prevented.
How does this work?
From birth on, the health status of your baby will be surveyed monthly by the clinical researcher. She will have telephone contact with you to administer health questionnaires. In case of any health complaints, extra medical check ups will take place by a resident paediatrician.
From birth until the first 6 months, the growth of your child will be evaluated every month. The length and weight data will be adopted from the community child health care center. After 6 months this will be done every 2 months.
Seven times from 4 months until 3 years of age you will be asked to let us take a small blood sample of your child. This will be done in the hospital. An anaesthetic cream will be used, so it does not hurt your child. The travel costs can be compensated.
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Participant 
