Evaluation of the outcome of clinical or home introduction of milk in children with Non-IgE-mediated cow*s Milk Allergy (ENIGMA trial)*

• Conditions: cow milk allergy; food allergy; 10016950

• Registration Number: NL-OMON53347
• Lead Sponsor: Martini Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

-maximum age of eighteen months;
-suspected to be allergic for cow*s milk

Exclusion Criteria

- children older than the age of eighteen months;
- sensitised for cow*s milk (i.e. SPT >3mm (in combination with positive
control >=3mm) or specific IgE >0.35 kU/L)
- patient suffers from acute (i.e. within one hour after cow*s milk had been
eaten) and moderate-severe IgE-mediated symptoms after ingestion of cow*s milk
(see Appendix, table A1);
- patient suffers from symptoms according to the FPIES criteria after ingestion
of cow*s milk (see table 2);
- patient uses beta blockers and/or prednisolone;
- patient suffers from uncontrolled respiratory symptoms or severe eczema or a
chronic condition because of which the patients cannot be included as judged by
the treating physician;
- parents are unable to adequately report the occurrence of possible symptoms
(e.g. mentally disabled or not native Dutch speaker).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the number of participants who are tolerant (negative<br /><br>outcome of the test) or intolerant (positive outcome of the test) for milk.<br /><br>The outcome is determined 1 week after the start of the test</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints of this study are:<br /><br><br /><br>•Percentage of patients with regular milk consumption). Milk consumption is<br /><br>based on normal daily intake for age<br /><br>Determined 6 weeks after completion of the test<br /><br><br /><br>•Percentage and type of reported symptoms<br /><br>Reported symptoms are classified according to predefined criteria<br /><br>Determined 6 weeks after completion of the test.<br /><br><br /><br>•Healthcare utilisation during the study period<br /><br>Healthcare utilisation is determined by evaluation of the number of physical<br /><br>and telephone consultations, and correspondence by mail.<br /><br>Determined 6 weeks after completion of the test</p><br>