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

NCT05785299 | Recruiting DMC

• 1 other identifier: ABR 83741
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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 milk; Diagnostic 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 milk DIAGNOSTIC_TEST

clinical introduction of cow's milk

Also known as: Oral food challenge test

Double blind placebo controlled challenge test

Placebo DIAGNOSTIC_TEST

clinical introduction of placebo

Also known as: Oral food challenge test

Double blind placebo controlled challenge test

Home introduction DIAGNOSTIC_TEST

home introduction of cow's milk

Home introduction test

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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:

• 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).

Sponsors & Collaborators

• Martini Hospital Groningen: lead

Study Sites (1)

Martini Hospital

Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity; Food Hypersensitivity

Interventions

Milk

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food 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; F.vanderPluijm@mzh.nl

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
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be analysed after all patients have ended the study period.
• Access Criteria: Request by mailing principal investigator

Locations

NL (1)