Basophil Activation Test cow's milk for replacement of the food challenge test

Recruiting

Conditions: cow's milk allergy
10001708

Registration Number: NL-OMON52026

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 700

Inclusion Criteria

Inclusion criteria (all criteria must be met with in b. one or more symptoms):
a. Age 0-12 years
b. Suspected of cow's milk allergy with one or more of the following complaints
after intake of cow's milk:
- angioedema
- urticaria
- sneezing and rhinitis <2 hours after feeding
- sensation of swelling in the throat and/or difficulty swallowing <2 hours
after feeding
- voice change/hoarseness <2 hours after feeding
- cough <2 hours after feeding
- wheezing and/or shortness of breath <2 hours after feeding
- loss of consciousness <2 hours after feeding
- vomiting or abdominal pain or diarrhoea <2 hours after feeding in children <4
years only in combination with IgE-mediated complaints in other tracts
c. Placed on a waiting list for a hospital food challenge test
d. Blood draw for cow*s milk sIgE and BAT < 3 months before the food challenge
test
e. Signed informed consent parents/guardians

Exclusion Criteria

Exclusion criteria (if one or more criteria are met, the child will be
excluded):
a. Age > 12 years
b. Suspicion of Food Protein-Induced Enterocolitis Syndrome (FPIES)
c. Eosinophilic esophagitis due to a cow's milk allergy
d. Suspected cow's milk allergy <4 years with crying and/or agitation and/or
eczema and/or abdominal pain and/or failure to
thrive and/or blood loss per anum and/or diarrhoea and/or reflux and/or
vomiting as the only manifestation of the allergy without
IgE-mediated symptoms in another organ system
e. Systemic immunosuppressant use
f. Other underlying chronic conditions (immunological, oncological, chromosomal
abnormalities).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The sensitivity, specificity, negative- and positive predictive value of the<br /><br>BAT. Effectiveness of replacement of the food<br /><br>challenge test by the BAT in diagnostic delay (and consequently quality of<br /><br>life) and in costs of diagnostics and prescription of<br /><br>hypoallergenic formula.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Cost reduction in diagnostics (replacement of the food challenge test by the<br /><br>BAT) and cost reduction in prescription of<br /><br>hypoallergenic formula due to reduction in diagnostic delay.<br /><br>2) Effect of reduction in diagnostic delay and burden of diagnostics on patient<br /><br>quality of life.</p><br>