Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05785299
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-02-24
Brief Title:
Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cows Milk Allergy
Sponsor:
Martini Hospital Groningen
Organization:
Martini Hospital Groningen
Study Overview
Official Title:
Evaluation of the Outcome of Clinical or Home Introduction of Milk in Children With Non-IgE-mediated Cows Milk Allergy ENIGMA Trial
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENIGMA
Brief Summary:
There are a lot of parents who believe that their child may not tolerate cows milk because they develop symptoms such as redness of the skin or they may vomit It is not always easy to find out if these infants should indeed avoid drinking cows milk or that the symptoms are caused by something else for instance because they have a viral illness The goal of the investigators is to find out if cows milk should be introduced in the hospital or if it can also be advised to perform the introduction at home to determine if an infant can drink cows milk without developing symptoms Half of the participants will drink cows milk in the hospital This test is performed on two days On one of the days cows milk will be offered On the other day a look-alike substance is offered The other half of the participants will drink cows milk at home by starting to drink a little bit of milk and in a few steps drink a normal bottle of cows milk The main question is whether both tests can be used to find out if an infant can drink cows milk without developing symptoms
Detailed Description:
Cows 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 cows 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 cows 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 cows milk allergy and potential over diagnosis is due to the overlap of symptoms with other common diseases in infants
The aim of this study is to compare the outcome of an adjusted DBPCFC and introduction at home of cows milk for children with a suspected non-IgE-mediated cows milk allergy
Patients with a suspected cows milk allergy will be randomized to a DBPCFC or home introduction of cows milk after sensitisation for cows milk has been excluded and parents have not reported severe symptoms during introduction of cows milk Outcome of both introduction methods will be based on predefined criteria For patients with a negative outcome of the test unrestricted exposure to cows milk is recommended In case of a positive outcome parents are recommended to gradually increase the amount of cows milk in their childs diet by means of the milk ladder During regular follow-up visits the investigators will inquire whether introduction of cows milk is successful and if needed motivate parents to continue further introduction Number of all consultations will be registered
The aim of this study is to compare the outcome of an adjusted DBPCFC and introduction at home of cows milk for children with a suspected non-IgE-mediated cows milk allergy
Patients with a suspected cows milk allergy will be randomized to a DBPCFC or home introduction of cows milk after sensitisation for cows milk has been excluded and parents have not reported severe symptoms during introduction of cows milk Outcome of both introduction methods will be based on predefined criteria For patients with a negative outcome of the test unrestricted exposure to cows milk is recommended In case of a positive outcome parents are recommended to gradually increase the amount of cows milk in their childs diet by means of the milk ladder During regular follow-up visits the investigators will inquire whether introduction of cows milk is successful and if needed motivate parents to continue further introduction Number of all consultations will be registered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None