Egg HypersensitivityTETINCT02487420
Gradual Egg-tolerance Induction in Hen's Egg Allergic Children
A study testing shorter or longer period of specific dietary restrictions in people with Egg Hypersensitivity, run by Dominque Bullens at 6 sites in Belgium.
Trial summary
1. 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… Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Egg Hypersensitivity
- What is being tested?
- shorter or longer period of specific dietary restrictions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 6 sitesBelgium
- Study dates
- 1 Jul 2015to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 -
Who cannot join
- 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 -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
Imelda Hospital, Bonheiden
Bonheiden
Sint-Jan
Bruges, 8000
Algemeen Ziekenhuis Maria Middelares
Ghent
Jessa Hospital
Hasselt
University Hospital of Leuven
Leuven, Vlaams-Brabant, 3000
Sint-Jan
Ostend, 8400
About this study
Official title: Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie)
- 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.
Read the 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.
- Conditions
- Egg Hypersensitivity
- Being tested
- shorter or longer period of specific dietary restrictions
- Medical subject headings
- Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shorter or longer period of specific dietary restrictionsBehavioural
step by step gradual introduction of egg containing food products
| Study group | Role | What they receive |
|---|---|---|
| Arm 18m | Other | 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 Receives: Behavioral: shorter or longer period of specific dietary restrictions |
| arm 30 m | Other | 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 Receives: Behavioral: shorter or longer period of specific dietary restrictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to complete egg tolerance
raw egg tolerance (eg in chocolate mousse)
Measured: 18 to 30 months
Secondary outcomes (1)
Measurement of specific IgE to egg white components to predict complete egg tolerance
Measured: 18 to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start1 Jul 2015
- Primary completionMay 2021
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Egg HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dominque Bullens
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Algemeen Ziekenhuis Maria Middelares, Imelda Hospital, Bonheiden, AZ Sint-Jan AV
- Responsible party
- Sponsor-investigator, Dominque Bullens, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Dominique MA Bullens, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487420
- Sponsor's protocol ID
- S57588
- Acronym
- TETI
- Status last verified
- Nov 2021
- First submitted
- 29 Jun 2015
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: data will be analysed and grouped before release
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie)
- ClinicalTrials.gov ID
- NCT02487420
- Acronym / sponsor ID
- TETI / S57588
- Conditions
- Egg Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Dominque BullensUniversity, hospital or other
- Collaborators
- Jessa Hospital, Algemeen Ziekenhuis Maria Middelares, Imelda Hospital, Bonheiden, AZ Sint-Jan AV
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- Apr 2022 (estimated)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 18m | Other | Behavioral: shorter or longer period of specific dietary restrictionsarm 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 30 m | Other | Behavioral: shorter or longer period of specific dietary restrictionsarm 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 |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (3 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shorter or longer period of specific dietary restrictionsstep by step gradual introduction of egg containing food products | Behavioural | Arm 18m, arm 30 m |
Primary outcome
time to complete egg tolerance
Time frame: 18 to 30 months
raw egg tolerance (eg in chocolate mousse)
1 secondary outcome
Measurement of specific IgE to egg white components to predict complete egg tolerance
Time frame: 18 to 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No. data will be analysed and grouped before release
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique MA Bullens, MD, PhD principal investigator
UZ Leuven
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shorter or longer period of specific dietary restrictions in people with Egg Hypersensitivity, run by Dominque Bullens at 6 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to complete egg tolerance (time frame: 18 to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.