The aim of this study is to compare the outcome of a clinical challenge test and home introduction of cow*s milk for children with a suspected non-IgE-mediated cow*s milk allergy. We want to evaluate the ability of both tests to determine the…
ID
Source
Brief title
Condition
- Food intolerance syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the number of participants who are tolerant (negative
outcome of the test) or intolerant (positive outcome of the test) for milk.
The outcome is determined 1 week after the start of the test
Secondary outcome
Secondary endpoints of this study are:
•Percentage of patients with regular milk consumption). Milk consumption is
based on normal daily intake for age
Determined 6 weeks after completion of the test
•Percentage and type of reported symptoms
Reported symptoms are classified according to predefined criteria
Determined 6 weeks after completion of the test.
•Healthcare utilisation during the study period
Healthcare utilisation is determined by evaluation of the number of physical
and telephone consultations, and correspondence by mail.
Determined 6 weeks after completion of the test
Background summary
Cow*s milk allergy (CMA) is the most common food allergy among infants. CMA can
be divided into immunoglobin E (IgE) and non-IgE-mediated allergy. In case of
IgE-mediated allergy, symptoms occur within two hours after ingestion, and are
potentially life-threatening. In patients without sensitisation, symptoms may
occur up to 48 hours after ingestion and predominantly affect the
gastrointestinal tract and skin. The gold standard to diagnose a cow*s milk
allergy is to perform a double-blind placebo controlled food challenge
(DBPCFC). Determination of DBPCFC outcome for non-IgE-mediated allergy can be
challenging due to delayed presentation of symptoms after the DBPCFC has been
performed. Furthermore, in the majority of infants with non-IgE-mediated cow*s
milk allergy, symptoms are mild and therefore introduction under medical
supervision is superfluous. To date, there is no validated diagnostic to
confirm a diagnosis of non-IgE-mediated cow*s milk allergy and potential over
diagnosis is due to the overlap of symptoms with other common diseases in
infants.
Study objective
The aim of this study is to compare the outcome of a clinical challenge test
and home introduction of cow*s milk for children with a suspected
non-IgE-mediated cow*s milk allergy. We want to evaluate the ability of both
tests to determine the tolerance for cow's milk and subsequently if regular
daily consumption of milk is comparable in these patients.
Study design
Patients with a suspected non IgE mediated cow*s milk allergy will be
randomized to a clinical challenge test or home introduction of cow*s milk. The
outcome of both introduction methods is based on predefined criteria. For
patients with a negative outcome of the test (=tolerant for milk) unrestricted
exposure to cow*s milk is recommended. In case of a positive outcome
(=intolerant for milk), parents are recommended to gradually increase the
amount of cow*s milk in their child*s diet by means of the *milk ladder*.
During regular follow-up visits we will inquire whether regular consumption of
an age appropriate portion of cow*s milk is successful. If needed, parents will
be motivated to continue further introduction and/or the schedule of the "milk
ladder" wil l be adjusted. Number of all consultations will be registered.
Intervention
An adjusted DBPCFC or standardised home introduction schedule for cow*s milk.
Study burden and risks
Most food allergies present at young age, because the majority of food products
are introduced at that time. This especially accounts for cow*s milk. A
relatively low number of IgE mediated cow*s milk allergies present with severe
reactions. On the contrary, the risk of severe reactions is negligible in
non-IgE-mediated cow*s milk allergy especially if FPIES is excluded.
Furthermore, many children who lack sensitisation, overgrow cow*s milk allergy
before the age of one year.1 Therefore, we aim to optimise the diagnostic
process in order to prevent unnecessary elimination. There is no additional
risk for participants. Both introduction methods are part of routine care in
our allergy centre. The dosing schedules are adjusted but the cumulative dose
does not exceed the dose recommended in the (inter) national guidelines.
van Swietenplein 1
Groningen 9728 NT
NL
van Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05785299 |
| CCMO | NL83741.000.23 |