search
Back to results

Gradual Egg-tolerance Induction in Hen's Egg Allergic Children (TETI)

Primary Purpose

Egg Hypersensitivity

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
shorter or longer period of specific dietary restrictions
Sponsored by
Dominque Bullens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Egg Hypersensitivity

Eligibility Criteria

12 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Children are at least 12 months old before introduction of heated egg is considered
  3. Children did not suffer from a moderate-to-severe anaphylaxis due to egg-ingestion at presentation
  4. Children have specific IgE levels to Gal d 1 below 1.2 kU/mL or passed cake provocation test -

Exclusion Criteria:

  1. Children had a moderate-to severe anaphylaxis due to egg ingestion
  2. Children are younger than 12 months old at the moment of passing heated egg open provocation test
  3. Parents are not able or not willing to test a certain step in the tolerance induction at home -

Sites / Locations

  • University Hospital of Leuven
  • Imelda Hospital, Bonheiden
  • Sint-Jan
  • Algemeen Ziekenhuis Maria Middelares
  • Jessa Hospital
  • Sint-Jan

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm 18m

arm 30 m

Arm Description

arm 18m: 6 months between step 1 and step 2; 6 months between step 2 and step 3, 3 months between all other steps step by step gradual introduction of egg containing food products during 18 months, unless next step can not be taken

arm 30m: 9 months between step 1 and step 2; 9 months between step 2 and step 3, 6 months between all other steps step by step gradual introduction of egg containing food products during 30 months, unless next step can not be taken

Outcomes

Primary Outcome Measures

time to complete egg tolerance
raw egg tolerance (eg in chocolate mousse)

Secondary Outcome Measures

Measurement of specific IgE to egg white components to predict complete egg tolerance

Full Information

First Posted
June 29, 2015
Last Updated
November 4, 2021
Sponsor
Dominque Bullens
Collaborators
Jessa Hospital, Algemeen Ziekenhuis Maria Middelares, Imelda Hospital, Bonheiden, AZ Sint-Jan AV
search

1. Study Identification

Unique Protocol Identification Number
NCT02487420
Brief Title
Gradual Egg-tolerance Induction in Hen's Egg Allergic Children
Acronym
TETI
Official Title
Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dominque Bullens
Collaborators
Jessa Hospital, Algemeen Ziekenhuis Maria Middelares, Imelda Hospital, Bonheiden, AZ Sint-Jan AV

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators here want to test the hypothesis that a total period of 18 months of gradual open introduction of a certain egg product with regard to full egg tolerance induction is not inferior when compared to a total period of 30 months gradual open introduction of a certain egg product (see steps for the specific egg products) after tolerance for baked egg has been obtained. The investigators also want to define step-specific 'tolerance-failures' and study the relevance of specific IgE to specific egg components to predict failures at each step.
Detailed Description
The investigators here want to test the hypothesis that a total period of 18 months of gradual open introduction of a certain egg product with regard to full egg tolerance induction is not inferior when compared to a total period of 30 months gradual open introduction of a certain egg product (see steps for the specific egg products) after tolerance to baked egg has been obtained. The investigators also want to define step-specific 'tolerance-failures' and study the relevance of specific IgE to specific egg components to predict failures at each step. Step 1: open baked egg test passed (either at home or in the hospital): this is routine clinical practice; afterwards daily intake of increasing amounts of heated egg (amounts to be noted in diary) Step 2: open provocation test at home with hard-boiled egg, both hen's egg white and yolk, passed; afterwards weekly intake of either hard-boiled egg white or yolk or both (amounts and days to be noted in diary) Step 3: open provocation test at home with waffles, omelet, pan cake or scrambled egg passed; afterwards weekly or two-weekly intake of one of these specific preparation forms or of the previous preparation forms (amounts, days and preparation to be noted in diary) Step 4: open provocation test at home with fried or poached egg or softly boiled egg with liquid yolk; afterwards regular intake of one of these preparation forms or one of the prior steps (amounts, days and preparation to be noted in diary) Step 5: open provocation test at home with raw egg: eg. In chocolate mousse; mayonnaise or tiramisu; afterwards unlimited intake of all egg containing preparation forms (for 3 months in both groups to be noted in the diary) If tolerance to a certain step is not yet present (this is: if any reaction occurred during the months registered between two steps), the next step will be postponed. The number of failures (any reaction in relation to egg ingestion), the type of reaction and the additional time period necessary before the next step can be taken, will be recorded. After each time period, the investigators will measure specific IgE to hen's egg white and to Gal d 1, as standard clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Egg Hypersensitivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 18m
Arm Type
Other
Arm Description
arm 18m: 6 months between step 1 and step 2; 6 months between step 2 and step 3, 3 months between all other steps step by step gradual introduction of egg containing food products during 18 months, unless next step can not be taken
Arm Title
arm 30 m
Arm Type
Other
Arm Description
arm 30m: 9 months between step 1 and step 2; 9 months between step 2 and step 3, 6 months between all other steps step by step gradual introduction of egg containing food products during 30 months, unless next step can not be taken
Intervention Type
Behavioral
Intervention Name(s)
shorter or longer period of specific dietary restrictions
Intervention Description
step by step gradual introduction of egg containing food products
Primary Outcome Measure Information:
Title
time to complete egg tolerance
Description
raw egg tolerance (eg in chocolate mousse)
Time Frame
18 to 30 months
Secondary Outcome Measure Information:
Title
Measurement of specific IgE to egg white components to predict complete egg tolerance
Time Frame
18 to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Children did not suffer from a moderate-to-severe anaphylaxis due to egg-ingestion at presentation Children have specific IgE levels to Gal d 1 below 1.2 kU/mL or passed cake provocation test - Exclusion Criteria: Children had a moderate-to severe anaphylaxis due to egg ingestion Children are younger than 12 months old at the moment of passing heated egg open provocation test Parents are not able or not willing to test a certain step in the tolerance induction at home -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique MA Bullens, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Imelda Hospital, Bonheiden
City
Bonheiden
Country
Belgium
Facility Name
Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Maria Middelares
City
Ghent
Country
Belgium
Facility Name
Jessa Hospital
City
Hasselt
Country
Belgium
Facility Name
Sint-Jan
City
Oostende
ZIP/Postal Code
8400
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data will be analysed and grouped before release

Learn more about this trial

Gradual Egg-tolerance Induction in Hen's Egg Allergic Children

We'll reach out to this number within 24 hrs