Trials Sponsors Conditions Drugs Pricing

Conditions

Cow Milk Allergy Food Allergy

Outcome Measures

Primary Outcomes (1)

Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction
We here want to test the hypothesis that a total period of 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only).
12 months

Secondary Outcomes (6)

Time to complete tolerance in all three arms
12 months
Quality of life in all three arms
12 months
Clinical reactions
12 months
Side effects
12 months
IL-10-producing cow's milk specific regulatory T and B cells
Three times in 12 months
+1 more secondary outcomes

Study Arms (4)

Stepwise introduction using gradually shorter heating of cow's milk proteins

OTHER

Step 1: open introduction of 20' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 3 months. Step 2: open introduction of 15' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 3 months. Step 3: open introduction of 10' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 3 months. Step 4: open introduction of 5' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 3 months.

Other: Implementation of cow's milk in decreasingly heated forms

Stepwise introduction using the Flemish Milk Ladder

OTHER

The first 5 steps of the Flemish Milk Ladder (each containing a, b and c part) will be gradually introduced at home, each step for 21 days (2-3X a week during 3 consecutive weeks after which 3 days "rest"). We consider the 6th step the equivalent of tolerance induction so step 6 will be allowed once the OFC with uncooked milk is passed.

Other: Implementation of cow's milk in decreasingly heated forms

Interventions

Implementation of cow's milk in decreasingly heated formsOther

Implementation of cow's milk in decreasingly heated forms in cow's milk allergic subjects, tolerant to heated cow's milk, to assess the influence on tolerance induction.

Stepwise introduction using gradually shorter heating of cow's milk proteinsStepwise introduction using the Flemish Milk Ladder

Implementation of heated cow's milkOther

Eligibility Criteria

Age1 Year - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Children (1-18y) had or have a clinical diagnosis of IgE mediated cow's milk allergy based on positive history as well as skin prick testing and/or specific IgE detection by CAPtest in an allergy clinic.
Children are at least 12 months old before introduction of heated cow's milk is considered.

Sponsors & Collaborators

Universitaire Ziekenhuizen KU Leuven
Otherlead

Study Sites (5)

Imelda Hospital Bonheiden

Bonheiden, Belgium

RECRUITING

Katrien Coppens, MDCONTACT

AZ Sint-Jan

Bruges, Belgium

RECRUITING

Kate Sauer, MDCONTACT

AZ Maria Middelares

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Food HypersensitivityMilk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Jasmine Leus, MD
Maria Middelares Hospital, Gent
PRINCIPAL INVESTIGATOR
Katrien Coppens, MD
Imelda Hospital, Bonheiden
PRINCIPAL INVESTIGATOR
Sophie Verelst, MD
KU Leuven and Jessa Hospital, Hasselt
PRINCIPAL INVESTIGATOR
Kate Sauer, MD
AZ Sint-Jan AV
PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique MA Bullens, Prof. MD

CONTACT

+32016343801 dominique.bullens@kuleuven.be

Marleen Jannis

CONTACT

+32016343801

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Clinic Head in Pediatrics-Allergy at UZ Leuven, Head of the Allergy and Clinical Immunology Research group at KU Leuven (prof., dr.)

Study Record Dates

First Submitted

March 19, 2024

First Posted

April 24, 2024

Study Start

April 22, 2024

Actual (reported)

Primary Completion

December 30, 2028

Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (4)

Stepwise introduction using gradually shorter heating of cow's milk proteins

Stepwise introduction using the Flemish Milk Ladder

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Control arm with introduction of 20' cooked cow's milk

Healthy age-matched subjects

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (4)

Stepwise introduction using gradually shorter heating of cow's milk proteins

Stepwise introduction using the Flemish Milk Ladder

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Control arm with introduction of 20' cooked cow's milk

Healthy age-matched subjects

You may not qualify if:

Data Sharing

Source record

Locations