Trials Sponsors Conditions Drugs Pricing

Conditions

Cow Milk Allergy Food Allergy

Outcome Measures

Primary Outcomes (1)

Number of participants with a positive or negative test
Positive (intolerant) or negative (tolerant) outcome of the introduction test
Determined 1 week after start of the test

Secondary Outcomes (3)

Regular milk consumption
Determined 6 weeks after completion of the test
Percentage and type of reported symptoms
Determined 6 weeks after completion of the test
Healthcare utilisation during the study period
Determined 6 weeks after completion of the test

Study Arms (2)

Double blind placebo controlled challenge test

ACTIVE COMPARATOR

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

Diagnostic Test: Cow's milkDiagnostic Test: Placebo

Home introduction test

ACTIVE COMPARATOR

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

Diagnostic Test: Home introduction

Interventions

Cow's milkDiagnostic test

clinical introduction of cow's milk

Also known as: Oral food challenge test

Double blind placebo controlled challenge test

PlaceboDiagnostic test

clinical introduction of placebo

Also known as: Oral food challenge test

Eligibility Criteria

Age1 Month - 18 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Martini Hospital Groningen
Otherlead

Study Sites (1)

Martini Hospital

Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Milk HypersensitivityFood Hypersensitivity

Interventions

Milk

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

Kamps, MD, PhD
Martini Ziekenhuis Groningen
PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamps, MD,PhD

CONTACT

31505246900 a.kamps@mzh.nl

van der Pluijm, RN

CONTACT

31505245984

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 27, 2023

Study Start

October 9, 2023

Actual (reported)

Primary Completion

June 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Double blind placebo controlled challenge test

Home introduction test

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Double blind placebo controlled challenge test

Home introduction test

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations