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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Month - 18 Months
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

- 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05785299
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Martini Hospital Groningen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kamps, MD, PhD
Principal Investigator Affiliation	Martini Ziekenhuis Groningen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow Milk Allergy, Food Allergy

Additional Details

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. The aim of this study is to compare the outcome of an adjusted DBPCFC and introduction at home of cow's milk for children with a suspected non-IgE-mediated cow's milk allergy. Patients with a suspected cow's milk allergy will be randomized to a DBPCFC or home introduction of cow's milk after sensitisation for cow's milk has been excluded and parents have not reported severe symptoms during introduction of cow's milk. Outcome of both introduction methods will be based on predefined criteria. For patients with a negative outcome of the test unrestricted exposure to cow's milk is recommended. In case of a positive outcome, 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 the investigators will inquire whether introduction of cow's milk is successful and if needed motivate parents to continue further introduction. Number of all consultations will be registered.

Arms & Interventions

Arms

Active Comparator: Double blind placebo controlled challenge test

Introduction of cow's milk by means of an adjusted double blind placebo controlled challenge test

Active Comparator: Home introduction test

Introduction of cow's milk by means of a standardized schedule

Interventions

Diagnostic Test: - Cow's milk

clinical introduction of cow's milk

Diagnostic Test: - Placebo

clinical introduction of placebo

Diagnostic Test: - Home introduction

home introduction of cow's milk

Contact a Trial Team

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International Sites

Martini Hospital, Groningen, Netherlands

Status

Recruiting

Address

Martini Hospital

Groningen, ,

Site Contact

a.kamps@mzh.nl

31505246900

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