An observational study in Cow Milk Allergy, sponsored by Rijnstate Hospital. Recruiting at 1 site in Netherlands. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Rijnstate Hospital · Observational
The prevalence of children suspected of a cow's milk allergy is 17% in the Netherlands. Cow's milk diagnosis is based on a food challenge test However, this food challenge test is expensive, time consuming, risky, with waiting lists of several months. This waiting time results in unnecessarily long-term use of expensive hypoallergenic milk formula Therefore, there is a great need to introduce a better and faster diagnostic test for cow's milk allergy diagnosis in standard care. The in vitro Basophil Activation Test (BAT) is cheap, quick (result \< 1 day, no waiting list), safe for the child and is a reliable alternative for the food challenge test to diagnose an IgE-mediated allergy. A diagnostic work-up with the BAT is expected to achieve a relevant reduction in the number of expensive and risky food challenges and the prescription of hypoallergenic formula. The reduction in diagnostic delay will increase quality of life.
Objective: Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test by the Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow's milk allergy in children.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 700 is above the median of 102 across 45 observational studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children suspected of an IgE-mediated cow's milk allergy and are eligible for a food challenge test at 2nd and 3rd line allergy centres.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Suspected of cow's milk allergy with one or more of the following complaints after intake of cow's milk:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Blood draw
The burden for child/parents in this study is low as it is limited to a single blood draw, which is already necessary for usual diagnostic care in about 70% of the children
Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk
Time frame: 3 months
Cost-effectiveness of the BAT cow's milk
Cost-effectiveness of the BAT cow's milk compared to the food challenge test
Time frame: 1 year
Food allergy Quality of life
Quality of life measured by The Food Allergy Quality of Life Questionnaire (FAQLQ-CF)
Time frame: Before and one month after the food challenge test
Health related Quality of life
Quality of life measured by Kidscreen-10
Time frame: Before and one month after the food challenge test
Started Nov 2021 (actual). Primary completion is estimated for Dec 2025, 49 months after the start.
How these figures are worked out, and which studies are left out of them.
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