Table 1 The DBPCFC study algorithm

Part 1

The test (performed on two separate days with a 1 week interval)

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No feedings from midnight onwards

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Admittance to pediatric day care ward at 8 AM.

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Physical examination by physician

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DBPCFC schedule

Step

Time (in minutes)

Amount (in ml)

Amount (in mg CMP)

1

0

1

18

2

20

10

180

3

40

20

360

4

60

30

540

5

80

40

720

6

100

60

1080

7

120

90

1620

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Physical examination by physician in case of suspected reaction; if confirmed the test is stopped

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Physical examination by physician 20 minutes after last dose

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Clinical observation continued until 1 hour after last dose

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Parents are instructed about home symptoms’ diary

Part 2

Interpretation of test results

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Envelope with randomization code is opened

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Diagnosis CMA is confirmed if symptoms appeared during or within 72 hours after verum feeding and not during or within 72 hours after placebo feeding. These symptoms have to be either identical to the presenting symptoms or severe objective symptoms.

Part 3

Dietary advice

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CMA: continue a diet free of CMP and repeat challenge in future

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No CMA: reintroduction of CMP over a 4 week period

Week

Amount of CMP in feeding

1

¼ cow’s milk containing feeding and ¾ hydrolyzed formula

2

1/3 cow’s milk containing feeding and 2/3 hydrolyzed formula

3

2/3 cows milk containing feeding and 1/3 hydrolyzed formula

4

Exclusively cow’s milk containing feeding

Part 4

Long term follow up

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Interview by telephone about the child’s diet and symptoms