Eosinophilic EsophagitisNCT06381219
Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial
A study testing Implementation of cow's milk in decreasingly heated forms and Implementation of hen's egg in decreasingly heated forms in people with Eosinophilic Esophagitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Implementation of cow's milk in decreasingly heated forms and Implementation of hen's egg in decreasingly heated forms
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Dec 2023to 31 Dec 2028
- 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
- All children (aged 12 months and older) presenting (since 1-1-2014: moment of diagnostic guideline standardization for pedEoE) with diagnosed pedEoE at UZ Leuven eliminating either hen's egg or cow's milk or both and in complete remission after their latest biopsy (no longer than 12 months earlier, but preferentially as short as possible after their latest biopsy) are eligible for the study. If the last biopsy has been performed more than 12 months earlier, a new gastro-duodenoscopy will be performed to verify remission and rule out e.g. active gastritis. If they are on PPI and/or local budesonide treatment, this should be stable for at least 3 months and will remain untouched during the entire study. We will include 18 pedEoE subjects suffering from cow's milk induced EoE and 18 suffering from hen's egg induced EoE.
Who cannot join
- Children younger than 12 months
- Children with active pedEoE
- Children who refuse to adhere to the protocol
- Children with associated IgE mediated hen's egg and/or cow's milk allergy with specific IgE antibody titers that predict active (baked egg and/or baked milk) food allergy with cut-off titers as used at the consultation of allergy (KLL). Those children will become eligible however if their titers decrease while the study is still open.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven Gasthuisberg
Leuven, Vlaams-Brabant, 3000
Dominique Bullens, Prof. Dr., 0032 16 34 38 01, dominique.bullens@kuleuven.be
Marleen Jannis, 0032 16 34 38 01, marleen.jannis@uzleuven.be
About this study
The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE.
Read the detailed description
If inclusion criteria are met, after obtaining informed consent from the parents (and when old enough, assent from the children) children with cow's milk and/or hen's egg induced pedEoE will be included in this pilot trial. Baseline blood will be obtained before in-house OFC procedure and serum will be stored for specific IgG4 analysis. In parallel, PBMCs will be isolated and stimulated in vitro with heat denatured proteins. B cells will be stained by 4-laserflow cytometry. IgG4 production in supernatants will be studied by ELISA (specific IgG4 by Immunocap 100). This procedure will be repeated during each gastroscopy.
Children will be provoked in-house, based on the written procedure available for heated egg or cow's milk provocation. Afterwards, they will introduce heated egg by cake or 20' boiled cow's milk at least three times a week for 8 weeks and will return to the hospital for a gastroscopy with biopsies. EoE remission will be studied on biopsies of the upper and lower esophagus by eosinophil staining within the routine anatomopathological laboratory within our hospital.
If remission remains, subjects will be invited to introduce less heated hen's egg or cow's milk for 8 weeks, after which they will return to the hospital for the second gastroscopy with similar procedure. This is repeated three times until 4' soft-boiled egg or 5' boiled cow's milk is introduced for 8 weeks. When remission remains after this introduction, the children and parents are offered the possibility to terminate the study or to introduce either raw egg (tiramisu or chocolate mousse) or uncooked UHT-treated cow's milk for 8 weeks after which gastroscopy with biopsies will be performed.
If remission is lost, they will return to the strict avoidance diet for at least 10 weeks after which they will return to the hospital for their second gastroscopy. Upon remission after avoidance, the children will remain eligible for another heat denatured food challenge (when on diet for both).
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Implementation of cow's milk in decreasingly heated forms, Implementation of hen's egg in decreasingly heated forms
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of cow's milk in decreasingly heated formsOther
Implementation of cow's milk in decreasingly heated forms to assess maintained remission of EoE
Implementation of hen's egg in decreasingly heated formsOther
Implementation of hen's egg in decreasingly heated forms to assess maintained remission of EoE
| Study group | Role | What they receive |
|---|---|---|
| Cow's milk allergen heat denaturation | Other | Children with an EoE in remission AND a previous diet excluding any form of cow's milk will undergo an oral food challenge with extensively heated cow's milk (20'). Afterwards they will be instructed to ensure regular intake of 20' heated cow's milk. After 8 weeks of (re)introduction they will be assessed for potential remaining remission (<15 eosinophils/hpf on esophagal biopsies). If remission is sustained, they will sequentially decrease the degree of heat denaturation by decreasing the cooking time: 15', 10' and 5' cooked cow's milk. At the end, parents will have the choice to add a final step of raw cow's milk. After every 8 weeks of every new step, a gastroscopy will be performed to assess maintained remission. If remission is lost, they will go back to a strict avoidance diet for at least 10 weeks. Receives: Other: Implementation of cow's milk in decreasingly heated forms |
| Hen's egg allergen heat denaturation | Other | Children with an EoE in remission AND a previous diet excluding any form of hen's egg will undergo an oral food challenge with strongly heated hen's egg (in cake). Afterwards they will be instructed to ensure regular intake of cake. After 8 weeks of (re)introduction they will be assessed for potential remaining remission (<15 eosinophils/hpf on esophagal biopsies). If remission is sustained, they will sequentially decrease the degree of heat denaturation as follows: hard-boiled egg, omelet and soft-boiled egg. At the end, parents will have the choice to add a final step of raw egg. After every 8 weeks of every new step, a gastroscopy will be performed to assess maintained remission. If remission is lost, they will go back to a strict avoidance diet for at least 10 weeks. Receives: Other: Implementation of hen's egg in decreasingly heated forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintained remission of EoE
Primary end-point of the study is to study the number of pedEoE children by inclusion on hen's egg and/or cow's milk free diet with potential remaining remission (<15 eosinophils/hpf on esophageal biopsies) after 8 weeks (re)introduction of heat-denatured hen's egg and/or cow's milk proteins (introduced sequentially as on the one hand baked egg (cake), hard-boiled egg, omelet and soft-boiled egg and on the other hand 20' cooked cow's milk, 15', 10' and 5' cooked cow's milk).
Measured: 40 weeks
Secondary outcomes (7)
Maintained remission only in step 1 of the diet
The number of pedEoE children in whom remission remain with introduction of cake and/or 20' cooked cow's milk (step 1), but no longer with less heated proteins.
Measured: Assessment of failed remission 8 weeks after step 2 but successful remission after step 1
Association of remission with circulating IgG4 levels
To study whether remission (>15 eosinophils per high-power field) is associated with specific circulating and/or local food protein IgG4 reduction (and increase upon unsuccessful introduction of less heated proteins). We will compare the IgG4 levels (expressed in g/L) in patients in remission and those not in remission.
Measured: Bloods will be taken during every gastroscopy
Association of remission with IgG4 levels on biopsy
To study whether remission (>15 eosinophils per high-power field) can be associated with changes in local IgG4 production that will be measured by biopsy staining and expressed in number of IgG4 positive plasma cells per high-power field. We will compare the local IgG4 production in patients in remission and those not in remission.
Measured: At every gastroscopy
In vitro B cell test to mimic B cell activation after stimulation
After PBMC isolation from the blood of pediatric patients, the PBMCs will be in vitro stimulated with food proteins. Then, B cell activation will be measured with flow cytometry by looking at the proportion of activated B cells compared to the total number of B cells.
Measured: Up to 6 months
Correlation between QoL and remission
Can we observe a correlation between Pediatric EoE PEESS v2.0 and Peds-QL scores (obtained in all pedEoE children participating in study s64441) and histologic remission?
Measured: Up to 45 weeks
Associated atopy
To study the presence of associated atopy (tree-, grass- or weed pollen or fungi allergy).
Measured: On inclusion with initial characteristics of the patients
Associated food allergies
To study the presence of associated typical IgE mediated food allergy (sensitization and documented symptoms).
Measured: On inclusion with initial characteristics of the patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start19 Dec 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominque Bullens, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Ilse Hoffman, Prof. Dr., Principal investigator, Co-investigator, pediatric gastro-enterologyGert De Hertogh, Prof. Dr., Principal investigator, Co-investigator, pathological anatomy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381219
- Sponsor's protocol ID
- s67001
- Status last verified
- May 2026
- First submitted
- 19 Dec 2023
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial
- ClinicalTrials.gov ID
- NCT06381219
- Acronym / sponsor ID
- s67001
- Conditions
- Eosinophilic Esophagitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Apr 2024 (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 objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE.
Detailed description
If inclusion criteria are met, after obtaining informed consent from the parents (and when old enough, assent from the children) children with cow's milk and/or hen's egg induced pedEoE will be included in this pilot trial. Baseline blood will be obtained before in-house OFC procedure and serum will be stored for specific IgG4 analysis. In parallel, PBMCs will be isolated and stimulated in vitro with heat denatured proteins. B cells will be stained by 4-laserflow cytometry. IgG4 production in supernatants will be studied by ELISA (specific IgG4 by Immunocap 100). This procedure will be repeated during each gastroscopy.
Children will be provoked in-house, based on the written procedure available for heated egg or cow's milk provocation. Afterwards, they will introduce heated egg by cake or 20' boiled cow's milk at least three times a week for 8 weeks and will return to the hospital for a gastroscopy with biopsies. EoE remission will be studied on biopsies of the upper and lower esophagus by eosinophil staining within the routine anatomopathological laboratory within our hospital.
If remission remains, subjects will be invited to introduce less heated hen's egg or cow's milk for 8 weeks, after which they will return to the hospital for the second gastroscopy with similar procedure. This is repeated three times until 4' soft-boiled egg or 5' boiled cow's milk is introduced for 8 weeks. When remission remains after this introduction, the children and parents are offered the possibility to terminate the study or to introduce either raw egg (tiramisu or chocolate mousse) or uncooked UHT-treated cow's milk for 8 weeks after which gastroscopy with biopsies will be performed.
If remission is lost, they will return to the strict avoidance diet for at least 10 weeks after which they will return to the hospital for their second gastroscopy. Upon remission after avoidance, the children will remain eligible for another heat denatured food challenge (when on diet for both).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow's milk allergen heat denaturation | Other | Other: Implementation of cow's milk in decreasingly heated formsChildren with an EoE in remission AND a previous diet excluding any form of cow's milk will undergo an oral food challenge with extensively heated cow's milk (20'). Afterwards they will be instructed to ensure regular intake of 20' heated cow's milk. After 8 weeks of (re)introduction they will be assessed for potential remaining remission (<15 eosinophils/hpf on esophagal biopsies). If remission is sustained, they will sequentially decrease the degree of heat denaturation by decreasing the cooking time: 15', 10' and 5' cooked cow's milk. At the end, parents will have the choice to add a final step of raw cow's milk. After every 8 weeks of every new step, a gastroscopy will be performed to assess maintained remission. If remission is lost, they will go back to a strict avoidance diet for at least 10 weeks. |
| Hen's egg allergen heat denaturation | Other | Other: Implementation of hen's egg in decreasingly heated formsChildren with an EoE in remission AND a previous diet excluding any form of hen's egg will undergo an oral food challenge with strongly heated hen's egg (in cake). Afterwards they will be instructed to ensure regular intake of cake. After 8 weeks of (re)introduction they will be assessed for potential remaining remission (<15 eosinophils/hpf on esophagal biopsies). If remission is sustained, they will sequentially decrease the degree of heat denaturation as follows: hard-boiled egg, omelet and soft-boiled egg. At the end, parents will have the choice to add a final step of raw egg. After every 8 weeks of every new step, a gastroscopy will be performed to assess maintained remission. If remission is lost, they will go back to a strict avoidance diet for at least 10 weeks. |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children (aged 12 months and older) presenting (since 1-1-2014: moment of diagnostic guideline standardization for pedEoE) with diagnosed pedEoE at UZ Leuven eliminating either hen's egg or cow's milk or both and in complete remission after their latest biopsy (no longer than 12 months earlier, but preferentially as short as possible after their latest biopsy) are eligible for the study. If the last biopsy has been performed more than 12 months earlier, a new gastro-duodenoscopy will be performed to verify remission and rule out e.g. active gastritis. If they are on PPI and/or local budesonide treatment, this should be stable for at least 3 months and will remain untouched during the entire study. We will include 18 pedEoE subjects suffering from cow's milk induced EoE and 18 suffering from hen's egg induced EoE.
Key exclusion criteria (4 listed)
- Children younger than 12 months
- Children with active pedEoE
- Children who refuse to adhere to the protocol
- Children with associated IgE mediated hen's egg and/or cow's milk allergy with specific IgE antibody titers that predict active (baked egg and/or baked milk) food allergy with cut-off titers as used at the consultation of allergy (KLL). Those children will become eligible however if their titers decrease while the study is still open.
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 |
|---|---|---|
| Implementation of cow's milk in decreasingly heated formsImplementation of cow's milk in decreasingly heated forms to assess maintained remission of EoE | Other | Cow's milk allergen heat denaturation |
| Implementation of hen's egg in decreasingly heated formsImplementation of hen's egg in decreasingly heated forms to assess maintained remission of EoE | Other | Hen's egg allergen heat denaturation |
Primary outcome
Maintained remission of EoE
Time frame: 40 weeks
Primary end-point of the study is to study the number of pedEoE children by inclusion on hen's egg and/or cow's milk free diet with potential remaining remission (<15 eosinophils/hpf on esophageal biopsies) after 8 weeks (re)introduction of heat-denatured hen's egg and/or cow's milk proteins (introduced sequentially as on the one hand baked egg (cake), hard-boiled egg, omelet and soft-boiled egg and on the other hand 20' cooked cow's milk, 15', 10' and 5' cooked cow's milk).
7 secondary outcomes
Maintained remission only in step 1 of the diet
Time frame: Assessment of failed remission 8 weeks after step 2 but successful remission after step 1
Association of remission with circulating IgG4 levels
Time frame: Bloods will be taken during every gastroscopy
Association of remission with IgG4 levels on biopsy
Time frame: At every gastroscopy
In vitro B cell test to mimic B cell activation after stimulation
Time frame: Up to 6 months
Correlation between QoL and remission
Time frame: Up to 45 weeks
Associated atopy
Time frame: On inclusion with initial characteristics of the patients
Associated food allergies
Time frame: On inclusion with initial characteristics of the patients
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 5 May 2026.
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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.
Ilse Hoffman, Prof. Dr. principal investigator
Co-investigator, pediatric gastro-enterology
Gert De Hertogh, Prof. Dr. principal investigator
Co-investigator, pathological anatomy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of cow's milk in decreasingly heated forms and Implementation of hen's egg in decreasingly heated forms in people with Eosinophilic Esophagitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Dominique Bullens, Prof. Dr. (0032016343801, dominique.bullens@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintained remission of EoE (time frame: 40 weeks). 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 May 2026.