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

Primary Purpose

Cow Milk Allergy, Food Allergy

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cow's milk
Placebo
Home introduction
Sponsored by
Martini Hospital Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cow Milk Allergy

Eligibility Criteria

1 Month - 18 Months (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Martini HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Double blind placebo controlled challenge test

Home introduction test

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with a positive or negative test
Positive (intolerant) or negative (tolerant) outcome of the introduction test

Secondary Outcome Measures

Regular milk consumption
Milk consumption is based on normal daily intake for age
Percentage and type of reported symptoms
Reported symptoms are classified according to predefined criteria
Healthcare utilisation during the study period
Healthcare utilisation is determined by evaluation of the number of physical and telephone consultations

Full Information

First Posted
February 24, 2023
Last Updated
October 23, 2023
Sponsor
Martini Hospital Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT05785299
Brief Title
Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy
Acronym
ENIGMA
Official Title
Evaluation of the Outcome of Clinical or Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy (ENIGMA Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Martini Hospital Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy, Food Allergy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double blind placebo controlled challenge test
Arm Type
Active Comparator
Arm Description
Introduction of cow's milk by means of an adjusted double blind placebo controlled challenge test
Arm Title
Home introduction test
Arm Type
Active Comparator
Arm Description
Introduction of cow's milk by means of a standardized schedule
Intervention Type
Diagnostic Test
Intervention Name(s)
Cow's milk
Other Intervention Name(s)
Oral food challenge test
Intervention Description
clinical introduction of cow's milk
Intervention Type
Diagnostic Test
Intervention Name(s)
Placebo
Other Intervention Name(s)
Oral food challenge test
Intervention Description
clinical introduction of placebo
Intervention Type
Diagnostic Test
Intervention Name(s)
Home introduction
Intervention Description
home introduction of cow's milk
Primary Outcome Measure Information:
Title
Number of participants with a positive or negative test
Description
Positive (intolerant) or negative (tolerant) outcome of the introduction test
Time Frame
Determined 1 week after start of the test
Secondary Outcome Measure Information:
Title
Regular milk consumption
Description
Milk consumption is based on normal daily intake for age
Time Frame
Determined 6 weeks after completion of the test
Title
Percentage and type of reported symptoms
Description
Reported symptoms are classified according to predefined criteria
Time Frame
Determined 6 weeks after completion of the test
Title
Healthcare utilisation during the study period
Description
Healthcare utilisation is determined by evaluation of the number of physical and telephone consultations
Time Frame
Determined 6 weeks after completion of the test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamps, MD,PhD
Phone
31505246900
Email
a.kamps@mzh.nl
First Name & Middle Initial & Last Name or Official Title & Degree
van der Pluijm, RN
Phone
31505245984
Email
F.vanderPluijm@mzh.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamps, MD, PhD
Organizational Affiliation
Martini Ziekenhuis Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martini Hospital
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol and data will be shared upon request
IPD Sharing Time Frame
Data will be analysed after all patients have ended the study period.
IPD Sharing Access Criteria
Request by mailing principal investigator

Learn more about this trial

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

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