INCA research protocol
5.3.1. Participants and reintroduction 5.3.1.a. Selection After the elimination phase, the responders, i.e. those children who have shown significant improvements in behaviour in response to the elimination diet, will proceed to the reintroduction phase. 5.3.1.b. Number of participants Earlier Dutch trial has shown that approximately 10% of the parents are unable to comply with the diet consistently during the elimination phase.(25,29) We expect that, out of the 50 families starting the elimination diet, 45 families will successfully complete the first phase. We assume that 60% of the 45 children concerned will respond to the diet,(see chapter 7) and we expect that nearly all families with a child that has responded to the diet will be motivated to proceed to the reintroduction phase. So approximately 27 children will presumably start with the reintroduction phase. 5.3.1.c. Reintroduction and measurements All foods without increased IgG value during the first blood test, i.e. foods with an IgG-0 value, and without increased IgE-value, will be reintroduced concurrently. To start the reintroduction phase, the results of the IgG and IgE analysis of the first blood samples will have to be known to the researcher before the end of the elimination diet. All other laboratory results will be made known at the end of the trial. To prevent bias in interpreting the child’s behaviour, all parents, of responders and nonresponders alike, will receive the results of the blood tests at the end of the trial. Measurements M4 and M5 will take place during the reintroduction phase, at week 11 and week 13. The questionnaires will be completed as described in chapter 5.4.
The children from the control group are still on the waiting list during this phase. The measurement points are equal to the measurement points of the intervention group and will take place in week 11 (M4) and week 13 (M5). (table II) The 5th measurement, in week 13, will be combined with the measurements by the blinded paediatrician (MBP2) and the second blood test. After M5 the INCA study ends. All children from the control group will be offered an opportunity to start the elimination diet.
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Appendix
5.3.2. Control group