RecruitingNot ApplicableNCT05785299

Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy

Evaluation of the Outcome of Clinical or Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy (ENIGMA Trial)


Sponsor

Martini Hospital Groningen

Enrollment

120 participants

Start Date

Oct 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

There are a lot of parents who believe that their child may not tolerate cow's 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 cow's 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 cow's 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 cow's milk without developing symptoms. Half of the participants will drink cow's milk in the hospital. This test is performed on two days. On one of the days cow's milk will be offered. On the other day a look-alike substance is offered. The other half of the participants will drink cow's milk at home by starting to drink a little bit of milk and in a few steps drink a normal bottle of cow's milk. The main question is whether both tests can be used to find out if an infant can drink cow's milk without developing symptoms.


Eligibility

Min Age: 1 MonthMax Age: 18 Months

Inclusion Criteria2

  • maximum age of eighteen months;
  • suspected to be allergic for cow's milk (based on medical history);

Exclusion Criteria7

  • 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
  • patient suffers from symptoms according to the FPIES criteria after ingestion of cow's milk
  • 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. insufficient language proficiency).

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Interventions

DIAGNOSTIC_TESTCow's milk

clinical introduction of cow's milk

DIAGNOSTIC_TESTPlacebo

clinical introduction of placebo

DIAGNOSTIC_TESTHome introduction

home introduction of cow's milk


Locations(1)

Martini Hospital

Groningen, Netherlands

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NCT05785299


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