Cow Milk AllergyNCT05064917
BAT Cow's Milk for the Replacement of the Food Challenge Test
An observational study of Cow Milk Allergy, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Blood draw
- How many people
- 700 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2021to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Age 0-12 years
- 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
Show all 14Show fewer
- 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
- Placed on a waiting list for a hospital food challenge test
- Blood draw for cow's milk sIgE and BAT < 3 months before the food challenge test. This blood draw will be simultaneously scheduled with a blood draw for regular diagnostics.
- Signed informed consent parents/guardians
Who cannot join
- Age > 12 years
- Suspicion of Food Protein-Induced Enterocolitis Syndrome (FPIES)
- Eosinophilic esophagitis due to a cow's milk allergy
- 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
- Systemic immunosuppressant use
- Other underlying chronic conditions (immunological, oncological, chromosomal abnormalities).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Janneke Ruinemans
Arnhem, Gelderland, 6815 AD
Janneke Ruinemans, Dr., 088 005 88888, JRuinemans-Koerts@rijnstate.nl
Eva Koffeman, Dr., 088 005 8888, ekoffeman@rijnstate.nl
About this study
Official title: Basophil Activation Test (BAT) Cow's Milk as a Replacement for the Expensive, Burdensome and Risky Food Challenge Tes
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.
- Conditions
- Cow Milk Allergy
- Being tested
- Blood draw
- Keywords
- Basophil Activation test, Cow's milk, oral food challenge
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Children with suspected cow's milk allergy | Not described Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk
Measured: 3 months
Secondary outcomes (3)
Cost-effectiveness of the BAT cow's milk
Cost-effectiveness of the BAT cow's milk compared to the food challenge test
Measured: 1 year
Food allergy Quality of life
Quality of life measured by The Food Allergy Quality of Life Questionnaire (FAQLQ-CF)
Measured: Before and one month after the food challenge test
Health related Quality of life
Quality of life measured by Kidscreen-10
Measured: Before and one month after the food challenge test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Nov 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alrijne Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Bernhoven Hospital, Catharina Ziekenhuis Eindhoven, Elkerliek Hospital, Erasmus Medical Center, Elisabeth-TweeSteden Ziekenhuis, Maasstadziekenhuis, Meander Medisch Centrum, OLVG, Spaarne Gasthuis, Franciscus Gasthuis, University Medical Center Groningen, UMC Utrecht, Viecurie Medisch Centrum voor Noord LImburg, Zuyderland Medisch Centrum
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064917
- Sponsor's protocol ID
- NL76893.091.21
- Status last verified
- May 2022
- First submitted
- 21 Sep 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basophil Activation Test (BAT) Cow's Milk as a Replacement for the Expensive, Burdensome and Risky Food Challenge Tes
- ClinicalTrials.gov ID
- NCT05064917
- Acronym / sponsor ID
- NL76893.091.21
- Conditions
- Cow Milk Allergy
- Keywords
- Basophil Activation test, Cow's milk, oral food challenge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Alrijne Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Bernhoven Hospital, Catharina Ziekenhuis Eindhoven, Elkerliek Hospital, Erasmus Medical Center, Elisabeth-TweeSteden Ziekenhuis, Maasstadziekenhuis, Meander Medisch Centrum, OLVG, Spaarne Gasthuis, Franciscus Gasthuis, University Medical Center Groningen, UMC Utrecht, Viecurie Medisch Centrum voor Noord LImburg, Zuyderland Medisch Centrum
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with suspected cow's milk allergy | – | Diagnostic Test: Blood draw |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (14 listed)
- Age 0-12 years
- Suspected of cow's milk allergy with one or more of the following complaints after intake of cow's milk:
- Placed on a waiting list for a hospital food challenge test
- Blood draw for cow's milk sIgE and BAT < 3 months before the food challenge test. This blood draw will be simultaneously scheduled with a blood draw for regular diagnostics.
- Signed informed consent parents/guardians
Key exclusion criteria (6 listed)
- Age > 12 years
- Suspicion of Food Protein-Induced Enterocolitis Syndrome (FPIES)
- Eosinophilic esophagitis due to a cow's milk allergy
- 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
- Systemic immunosuppressant use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawThe 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 test | Children with suspected cow's milk allergy |
Primary outcome
Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk
Time frame: 3 months
3 secondary outcomes
Cost-effectiveness of the BAT cow's milk
Time frame: 1 year
Food allergy Quality of life
Time frame: Before and one month after the food challenge test
Health related Quality of life
Time frame: Before and one month after the food challenge test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
Related trials for Cow Milk Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow Milk Allergy, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janneke Ruinemans, Dr (088-0058888, JRuinemans-Koerts@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the in vitro Basophil Activation Test (BAT) Cow's Milk (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.