Egg HypersensitivityTETI-IINCT04677790
Gradual Egg-tolerance Induction in Hen's Egg Allergic Children Who Tolerate Baked Egg (TETI-II Study)
A study testing assigned period of specific dietary restrictions in people with Egg Hypersensitivity, run by Dominque Bullens at 4 sites in Belgium.
Trial summary
The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product with regard to full egg tolerance induction. 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?
- assigned 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
- 62 participants
- Where
- 4 sitesBelgium
- Study dates
- 9 Dec 2020to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 grade 4 anaphylaxis due to egg-ingestion at presentation (for grade 4 anaphylaxis, see EAACI anaphylaxis guidelines, Muraro A et al, Allergy. 2014 Aug;69(8):1008-25).
- Children have specific IgE levels to Gal d 1 below 1.2 kU/mL (12-24 months) or below 5 kU/mL (>24 months) or have a level that predicts a good chance (>75%) to pass the baked egg provocation test by cake (see Bartnikas LM et al, J Allergy Clin Immunol Pract 2013; 1: 354-360) and/or children passed baked egg provocation test by cake executed on clinical judgement.
Who cannot join
- Children had grade 4 anaphylaxis (for grade 4 anaphylaxis, see EAACI anaphylaxis guidelines, Muraro A et al, Allergy. 2014 Aug;69(8):1008-25) due to egg ingestion
- Children are younger than 12 months old at the moment of passing cake open provocation test
- Parents are not able or not willing to adhere to a certain egg step-containing diet on a regular basis at home
- Parents and/or children are not willing to give IC/assent
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Imelda Hospital Bonheiden
Bonheiden
Sint-Jan
Bruges
AZ maria middelares
Ghent, 9000
University Hospital of Leuven
Leuven, Vlaams-Brabant, 3000
About this study
The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product with regard to full egg tolerance induction.
Read the detailed description
- The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product (see steps for the specific egg products) with regard to full egg tolerance induction. 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 10 minutes 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 omelet, pancake 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 4 minutes 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 with the length of the previous step. 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.
- The investigators will also study the time to complete tolerance in the complete cohort (this is the time to complete step 1 to step 5).
- Furthermore, the investigators want to study the induction of IL-10-producing ICOS-expressing hen's egg specific Treg cells in vitro paralleling tolerance induction.
- The investigators also want to study whether we can correlate the results of the in-house developed in vitro BAT with different heated hen's egg ingredients to the results of the egg provocation test and whether BAT could substitute for egg OFC tests for the different steps in the future.
- Conditions
- Egg Hypersensitivity
- Being tested
- assigned 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.
assigned period of specific dietary restrictionsBehavioural
Step by step gradual introduction of egg containing food products
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: Behavioral: assigned 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
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.
Measured: 12 to 20 months
Secondary outcomes (6)
The proportion of children evolving from any step to the next step within anticipated time period
The proportion of children evolving from any step to the next step within anticipated time period
Measured: 3 to 5 months
Influence of age at inclusion in relation to the proportion of failures
Influence of age at inclusion in relation to the proportion of failures
Measured: 12 to 20 months
Influence of specific IgE of hen's egg and/or components in relation to the proportion of failures
Influence of specific IgE of hen's egg and/or components in relation to the proportion of failures
Measured: 12 to 20 months
Influence of the dietary intake of the specific egg-containing products in relation to the proportion of failures
Influence of the dietary intake of the specific egg-containing products (in number of times a week and in portion) in relation to the proportion of failures
Measured: 12 to 20 months
Induction of Treg over time in parallel to gradual complete hen's egg tolerance induction.
We will study the difference in ICOS-expression as well as IL-10/IL-5 \& IL-10/IL-4 ratio at enrollment between healthy and egg-allergic children
Measured: 12 to 20 months
Can in vitro BAT for a certain step predict tolerance?
Do the results of the BAT with different heated hen's egg ingredients correlate with the egg intake at home?
Measured: 12 to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start9 Dec 2020
- Primary completion2 Jul 2025
- Study completionJul 2026 (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
- Model description
- After obtaining informed consent from the parents and oral or written assent from the children (where appropriate) we will randomize the children 1:1 in two groups, anticipated to be 12 and 20 months. Randomization by dice: even: very-short arm (12 months), uneven: short arm (20 months).
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominque Bullens
- Sponsor type
- University, hospital or other
- Collaborators
- Imelda Hospital, Bonheiden, AZ Sint-Jan AV
- Responsible party
- Sponsor-investigator, Dominque Bullens, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Dominique Bullens, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677790
- Sponsor's protocol ID
- S64538
- Acronym
- TETI-II
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gradual Egg-tolerance Induction in Hen's Egg Allergic Children Who Tolerate Baked Egg (TETI-II Study)
- ClinicalTrials.gov ID
- NCT04677790
- Acronym / sponsor ID
- TETI-II / S64538
- Conditions
- Egg Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Dominque BullensUniversity, hospital or other
- Collaborators
- Imelda Hospital, Bonheiden, AZ Sint-Jan AV
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Dec 2020 (actual)
- 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 want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product with regard to full egg tolerance induction.
Detailed description
- The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product (see steps for the specific egg products) with regard to full egg tolerance induction. 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 10 minutes 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 omelet, pancake 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 4 minutes 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 with the length of the previous step. 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.
- The investigators will also study the time to complete tolerance in the complete cohort (this is the time to complete step 1 to step 5).
- Furthermore, the investigators want to study the induction of IL-10-producing ICOS-expressing hen's egg specific Treg cells in vitro paralleling tolerance induction.
- The investigators also want to study whether we can correlate the results of the in-house developed in vitro BAT with different heated hen's egg ingredients to the results of the egg provocation test and whether BAT could substitute for egg OFC tests for the different steps in the future.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After obtaining informed consent from the parents and oral or written assent from the children (where appropriate) we will randomize the children 1:1 in two groups, anticipated to be 12 and 20 months. Randomization by dice: even: very-short arm (12 months), uneven: short arm (20 months).
| Arm | Type | Receives |
|---|---|---|
| "Very short arm" (12 months) | Active comparator | Behavioral: assigned period of specific dietary restrictionsVery 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. |
| "Short arm" (20 months) | Active comparator | Behavioral: assigned period of specific dietary restrictionsShort 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. |
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 grade 4 anaphylaxis due to egg-ingestion at presentation (for grade 4 anaphylaxis, see EAACI anaphylaxis guidelines, Muraro A et al, Allergy. 2014 Aug;69(8):1008-25).
- Children have specific IgE levels to Gal d 1 below 1.2 kU/mL (12-24 months) or below 5 kU/mL (>24 months) or have a level that predicts a good chance (>75%) to pass the baked egg provocation test by cake (see Bartnikas LM et al, J Allergy Clin Immunol Pract 2013; 1: 354-360) and/or children passed baked egg provocation test by cake executed on clinical judgement.
Key exclusion criteria (4 listed)
- Children had grade 4 anaphylaxis (for grade 4 anaphylaxis, see EAACI anaphylaxis guidelines, Muraro A et al, Allergy. 2014 Aug;69(8):1008-25) due to egg ingestion
- Children are younger than 12 months old at the moment of passing cake open provocation test
- Parents are not able or not willing to adhere to a certain egg step-containing diet on a regular basis at home
- Parents and/or children are not willing to give IC/assent
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 |
|---|---|---|
| assigned period of specific dietary restrictionsStep by step gradual introduction of egg containing food products | Behavioural | "Short arm" (20 months), "Very short arm" (12 months) |
Primary outcome
Time to complete egg tolerance
Time frame: 12 to 20 months
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.
6 secondary outcomes
The proportion of children evolving from any step to the next step within anticipated time period
Time frame: 3 to 5 months
Influence of age at inclusion in relation to the proportion of failures
Time frame: 12 to 20 months
Influence of specific IgE of hen's egg and/or components in relation to the proportion of failures
Time frame: 12 to 20 months
Influence of the dietary intake of the specific egg-containing products in relation to the proportion of failures
Time frame: 12 to 20 months
Induction of Treg over time in parallel to gradual complete hen's egg tolerance induction.
Time frame: 12 to 20 months
Can in vitro BAT for a certain step predict tolerance?
Time frame: 12 to 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- 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 Bullens, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assigned period of specific dietary restrictions in people with Egg Hypersensitivity, run by Dominque Bullens at 4 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 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
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: 12 to 20 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 11 Mar 2026.