Conditions

Egg Hypersensitivity

Outcome Measures

Primary Outcomes (1)

Time to complete egg tolerance
The proportion of children in each group evolving from step 1 to step 5 within the anticipated time period (12 versus 20 months), followed by 3 versus 5 months of uneventful liberal egg intake for observation after step 5.
12 to 20 months

Secondary Outcomes (6)

The proportion of children evolving from any step to the next step within anticipated time period
3 to 5 months
Influence of age at inclusion in relation to the proportion of failures
12 to 20 months
Influence of specific IgE of hen's egg and/or components in relation to the proportion of failures
12 to 20 months
Influence of the dietary intake of the specific egg-containing products in relation to the proportion of failures
12 to 20 months
Induction of Treg over time in parallel to gradual complete hen's egg tolerance induction.
12 to 20 months
+1 more secondary outcomes

Study Arms (2)

"Very short arm" (12 months)

ACTIVE COMPARATOR

Very short arm (12 months): 3 months between every step. Step by step gradual introduction of egg containing food products during 12 months, unless next step can not be taken.

Behavioral: assigned period of specific dietary restrictions

"Short arm" (20 months)

ACTIVE COMPARATOR

Short arm (20 months): 5 months between every step. Step by step gradual introduction of egg containing food products during 20 months, unless next step can not be taken.

Behavioral: assigned period of specific dietary restrictions

Interventions

assigned period of specific dietary restrictionsBehavioral

Step by step gradual introduction of egg containing food products

"Short arm" (20 months)"Very short arm" (12 months)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Months - 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 hen's egg 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 egg is considered

Sponsors & Collaborators

Study Sites (4)

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Imelda Hospital Bonheiden

Bonheiden, Belgium

Sint-Jan

Bruges, Belgium

AZ maria middelares

Ghent, 9000, Belgium

MeSH Terms

Conditions

Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Dominique Bullens, MD, PhD
Universitaire Ziekenhuizen KU Leuven
PRINCIPAL INVESTIGATOR

Gradual Egg-tolerance Induction in Hen's Egg Allergic Children Who Tolerate Baked Egg (TETI-II Study)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

"Very short arm" (12 months)

"Short arm" (20 months)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

"Very short arm" (12 months)

"Short arm" (20 months)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations