Eosinophilic Esophagitis (EoE)NCT06756581
Tolerability of Baked Dairy Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger
A study testing baked milk product diet in people with Eosinophilic Esophagitis (EoE), run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction. While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- baked milk product diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2025to Dec 2030
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients diagnosed with EoE age ≤ 17.5 years at inclusion who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction
- Verified histologic remission on milk-free diet on endoscopy prior to intervention
- Proton-pump inhibitors may be used if treatment is maintained at the same dose from the screening endoscopy throughout the trial period, and was used at the time that milk was demonstrated to be the triggering food
- Ability to consent to enrollment in the trial - legal guardians with joint consent for patients >10 years.
Who cannot join
- Patients with clinical IgE-mediated milk allergy
- Provisional exclusion: patients without a known IgE-mediated allergic reaction to milk who have a positive RAST (as per local reference range) or positive skin-prick test for cow milk or goat milk must be assessed by a certified allergist/immunologist and cleared for the trial by a supervised milk challenge.
- Use of inhaled corticosteroids for more than 5 days per month during the trial period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction.
While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease.
Read more
The most frequent dietary trigger for EoE is milk, but there is limited data on the effect of baked dairy . Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of baked dairy in patients with cow's milk triggered EoE.
Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Some patients tolerate baked dairy products, which are less allergenic due to denaturation of proteins through heat. The potential for baked dairy to be included in the diet of milk-triggered EoE patients remains unexplored in current guidelines.
The aim of this study is to assess tolerability and safety of baked dairy in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.
Read the detailed description
This prospective, multi-center trial will include patients with EoE diagnosed according to the accepted definitions: symptoms of esophageal dysfunction and >15 Eos/HPF on an esophageal biopsy, who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction.
Following full informed consent of the patient / guardians, patients will be offered to join the trial to assess their tolerance to baked dairy.
Due to the theoretical risk of developing IgE-mediated allergy on prolonged food protein type restriction, RAST-testing or skin-prick testing to cow milk will be undertaken to exclude IgE-mediated sensitization prior to introduction of baked daury. In patients with positive results, candidates can elect to withdraw from the study or alternatively an allergist will be consulted to consider the appropriateness of a medically observed baked dairy challenge.
Strict compliance with milk-free diet will be re-enforced for not less than 6 weeks prior to the patient's closest routine follow-up endoscopy. Baseline symptom profile will be recorded. Baseline endoscopy with routine biopsies (defined below) will be performed as part of the routine scheduled follow-up endoscopy as recommended by guidelines, in order to confirm histologic remission of EoE. Patients with baseline esophageal inflammation will be excluded from the study. Patients in histologic remission will be commenced on bake dairy containing diet with not less than 1 daily serving.
Repeat symptom profile assessed at 6 weeks and at 12 weeks, with repeat endoscopy with routine biopsies at 12±2 weeks. If symptoms recur prior to 12 weeks, endoscopy may be moved up earlier, from 6 weeks onwards.
Patients in clinical and histologic remission at 12 weeks will be followed until week 52 with repeat scheduled endoscopy. Baked dairy consumption will be permitted during the follow-up, but not be required daily as in the first time period. A baked dairy consumption diary will be collected over the 4 weeks prior to this endoscopy.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- baked milk product diet
- Keywords
- Eosinophilic Esophagitis (EoE)
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baked milk product dietOther
Elimination of none baked cow milk from diet . Baked cow milk containing diet.
| Study group | Role | What they receive |
|---|---|---|
| Tolerability of baked milk products in eosinophilic esophagitis patients with cow milk trigger | Experimental | Elimination of none baked cow milk from diet . Baked milk products containing diet. Receives: Other: baked milk product diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic remission rate following 12 weeks exposure to ingested baked dairy products
will be assessed on biopsies collected at week 12 during upper endoscopy
Measured: 12 weeks exposure to ingested baked dairy products
Secondary outcomes (4)
Symptom scores following 12 weeks exposure to ingested baked dairy
Symptom profile assessed by PEESSv2.0 at 6 weeks and at 12 weeks, with repeat endoscopy with routine biopsies at 12 weeks
Measured: 12 weeks exposure to ingested baked dairy
Endoscopic remission rate following 12 weeks exposure to ingested baked dairy
endoscopy with routine biopsies at 12 weeks
Measured: 2 weeks exposure to ingested baked dairy
Endoscopic improvement following 12 weeks exposure to ingested baked dairy
endoscopy with routine biopsies at 12 weeks
Measured: 12 weeks exposure to ingested baked dairy
Safety of cow's milk challenge
In patients with any prior suspicion of IgE-mediated cow's milk allergy including any suspicious rash or other symptoms on previous exposure, will be referred to a pediatric immunologist for assessment and consideration of RAST test or skin-prick test, with a supervised challenge, if deemed necessary, prior to enrollment in the trial. Number of participants without a positive RAST test or skin-prick test
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Mar 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oren Ledder, MD, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756581
- Sponsor's protocol ID
- EoE tolerability of baked milk
- Status last verified
- May 2025
- First submitted
- 26 Dec 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of Baked Dairy Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger
- ClinicalTrials.gov ID
- NCT06756581
- Acronym / sponsor ID
- EoE tolerability of baked milk
- Conditions
- Eosinophilic Esophagitis (EoE)
- Keywords
- Eosinophilic Esophagitis (EoE)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 3 Jan 2025 (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.
Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction.
While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease.
The most frequent dietary trigger for EoE is milk, but there is limited data on the effect of baked dairy . Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of baked dairy in patients with cow's milk triggered EoE.
Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Some patients tolerate baked dairy products, which are less allergenic due to denaturation of proteins through heat. The potential for baked dairy to be included in the diet of milk-triggered EoE patients remains unexplored in current guidelines.
The aim of this study is to assess tolerability and safety of baked dairy in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.
Detailed description
This prospective, multi-center trial will include patients with EoE diagnosed according to the accepted definitions: symptoms of esophageal dysfunction and >15 Eos/HPF on an esophageal biopsy, who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction.
Following full informed consent of the patient / guardians, patients will be offered to join the trial to assess their tolerance to baked dairy.
Due to the theoretical risk of developing IgE-mediated allergy on prolonged food protein type restriction, RAST-testing or skin-prick testing to cow milk will be undertaken to exclude IgE-mediated sensitization prior to introduction of baked daury. In patients with positive results, candidates can elect to withdraw from the study or alternatively an allergist will be consulted to consider the appropriateness of a medically observed baked dairy challenge.
Strict compliance with milk-free diet will be re-enforced for not less than 6 weeks prior to the patient's closest routine follow-up endoscopy. Baseline symptom profile will be recorded. Baseline endoscopy with routine biopsies (defined below) will be performed as part of the routine scheduled follow-up endoscopy as recommended by guidelines, in order to confirm histologic remission of EoE. Patients with baseline esophageal inflammation will be excluded from the study. Patients in histologic remission will be commenced on bake dairy containing diet with not less than 1 daily serving.
Repeat symptom profile assessed at 6 weeks and at 12 weeks, with repeat endoscopy with routine biopsies at 12±2 weeks. If symptoms recur prior to 12 weeks, endoscopy may be moved up earlier, from 6 weeks onwards.
Patients in clinical and histologic remission at 12 weeks will be followed until week 52 with repeat scheduled endoscopy. Baked dairy consumption will be permitted during the follow-up, but not be required daily as in the first time period. A baked dairy consumption diary will be collected over the 4 weeks prior to this endoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolerability of baked milk products in eosinophilic esophagitis patients with cow milk trigger | Experimental | Other: baked milk product dietElimination of none baked cow milk from diet . Baked milk products containing diet. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All patients diagnosed with EoE age ≤ 17.5 years at inclusion who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction
- Verified histologic remission on milk-free diet on endoscopy prior to intervention
- Proton-pump inhibitors may be used if treatment is maintained at the same dose from the screening endoscopy throughout the trial period, and was used at the time that milk was demonstrated to be the triggering food
- Ability to consent to enrollment in the trial - legal guardians with joint consent for patients >10 years.
Key exclusion criteria (3 listed)
- Patients with clinical IgE-mediated milk allergy
- Provisional exclusion: patients without a known IgE-mediated allergic reaction to milk who have a positive RAST (as per local reference range) or positive skin-prick test for cow milk or goat milk must be assessed by a certified allergist/immunologist and cleared for the trial by a supervised milk challenge.
- Use of inhaled corticosteroids for more than 5 days per month during the trial period.
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 |
|---|---|---|
| baked milk product dietElimination of none baked cow milk from diet . Baked cow milk containing diet. | Other | Tolerability of baked milk products in eosinophilic esophagitis patients with cow milk trigger |
Primary outcome
Histologic remission rate following 12 weeks exposure to ingested baked dairy products
Time frame: 12 weeks exposure to ingested baked dairy products
will be assessed on biopsies collected at week 12 during upper endoscopy
4 secondary outcomes
Symptom scores following 12 weeks exposure to ingested baked dairy
Time frame: 12 weeks exposure to ingested baked dairy
Endoscopic remission rate following 12 weeks exposure to ingested baked dairy
Time frame: 2 weeks exposure to ingested baked dairy
Endoscopic improvement following 12 weeks exposure to ingested baked dairy
Time frame: 12 weeks exposure to ingested baked dairy
Safety of cow's milk challenge
Time frame: 36 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 22 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Eosinophilic Esophagitis (EoE)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
Active, not recruitingPhase 2
A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
Eosinophilic Esophagitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing baked milk product diet in people with Eosinophilic Esophagitis (EoE), run by Shaare Zedek Medical Center at 1 site in Israel.
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: enrolling by invitation, as of the sponsor's last update on 22 May 2025. 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 Israel. 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?
Histologic remission rate following 12 weeks exposure to ingested baked dairy products (time frame: 12 weeks exposure to ingested baked dairy products). 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 22 May 2025.