Eosinophilic EsophagitisNCT05083156
Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The investigators seek to assess the efficacy of removing cow's milk from an EoE patient's diet. This will be determined by esophageal inflammation and clinical and histological response to the milk elimination treatment. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Diet Change
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2027
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The sample size was determined based on the one-proportion non-inferiority test. The investigators recruited 54 subjects throughout the recruitment period.
Who may be able to join
- Patients aged 1-18
- Patients who meet the criteria for diagnosis of EoE with ≥15 eosinophils per high power field and who had been previously treated with an adequate dose of PPI for 6-8 weeks or had a normal 24 hour ph probe study will be recruited from the patients seen by one of the physicians in the EoE clinic at Lurie Children's and other participating centers
- Patients who agree to cow's milk elimination diet as their treatment of EoE
Who cannot join
- Patients who started on oral or swallowed steroids (prior use of steroids that was discontinued more than two months prior to enrollment does not constitute an exclusion criterion)
- Patients who are unable to tolerate the cow's milk elimination diet
- Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Childjren's Hospital of Chicago
Chicago, Illinois, 60611
About this study
The investigators seek to assess the efficacy of removing cow's milk from an EoE patient's diet. This will be determined by esophageal inflammation and clinical and histological response to the milk elimination treatment.
Read the detailed description
The dietary approach is based on the hypothesis that food antigen(s) trigger eosinophilic inflammation and clinical and histological remission can be induced by identifying and excluding the causative food antigen(s). It is believed that eliminating causative food antigen(s) target the cause and thus induces long term remission.
This process is difficult as it requires multiple, invasive endoscopies and introduces the possibility of iatrogenic effects such as nutrient deficiency due to simultaneous multiple food eliminations. In addition, patient compliance may be compromised, both intentionally and unintentionally as many families report the elimination process to be both confusing and frustrating.
This prospective study eliminating only cow's milk proteins, which are a common cause of esophageal inflammation in patients with eosinophilic esophagitis, will assess the histological response in a cohort of children receiving care at Lurie Children's.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Diet Change
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet ChangeOther
Observation Cohort will be observed for treatment response to elimination of cow's milk
| Study group | Role | What they receive |
|---|---|---|
| Milk Elimination | cohort will be observed for treatment response to elimination of cow's milk Receives: Other: Diet Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the efficacy of the empiric single food elimination diet of eliminating cows milk
Participants who have eliminated cow's milk will be clinically assessed to determine if histological remission, measured by Eos/hpf, was induced under this diet for children with EOE
Measured: 1 year
Secondary outcomes (1)
Correlate esophageal counts with age of participant as a predictor of response
Participant ages will be used in statistical analysis with eosinophil counts to determine if age is a predictor of response to treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study startMar 2012
- Primary completionApr 2017
- Study completionDec 2027 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Wechsler, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Joshua B Wechsler, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083156
- Sponsor's protocol ID
- 2012-14865
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT05083156
- Acronym / sponsor ID
- 2012-14865
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Oct 2021 (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 seek to assess the efficacy of removing cow's milk from an EoE patient's diet. This will be determined by esophageal inflammation and clinical and histological response to the milk elimination treatment.
Detailed description
The dietary approach is based on the hypothesis that food antigen(s) trigger eosinophilic inflammation and clinical and histological remission can be induced by identifying and excluding the causative food antigen(s). It is believed that eliminating causative food antigen(s) target the cause and thus induces long term remission.
This process is difficult as it requires multiple, invasive endoscopies and introduces the possibility of iatrogenic effects such as nutrient deficiency due to simultaneous multiple food eliminations. In addition, patient compliance may be compromised, both intentionally and unintentionally as many families report the elimination process to be both confusing and frustrating.
This prospective study eliminating only cow's milk proteins, which are a common cause of esophageal inflammation in patients with eosinophilic esophagitis, will assess the histological response in a cohort of children receiving care at Lurie Children's.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milk Elimination | – | Other: Diet Changecohort will be observed for treatment response to elimination of cow's milk |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The sample size was determined based on the one-proportion non-inferiority test. The investigators recruited 54 subjects throughout the recruitment period.
Key inclusion criteria (3 listed)
- Patients aged 1-18
- Patients who meet the criteria for diagnosis of EoE with ≥15 eosinophils per high power field and who had been previously treated with an adequate dose of PPI for 6-8 weeks or had a normal 24 hour ph probe study will be recruited from the patients seen by one of the physicians in the EoE clinic at Lurie Children's and other participating centers
- Patients who agree to cow's milk elimination diet as their treatment of EoE
Key exclusion criteria (3 listed)
- Patients who started on oral or swallowed steroids (prior use of steroids that was discontinued more than two months prior to enrollment does not constitute an exclusion criterion)
- Patients who are unable to tolerate the cow's milk elimination diet
- Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis
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 |
|---|---|---|
| Diet ChangeObservation Cohort will be observed for treatment response to elimination of cow's milk | Other | Milk Elimination |
Primary outcome
Demonstrate the efficacy of the empiric single food elimination diet of eliminating cows milk
Time frame: 1 year
Participants who have eliminated cow's milk will be clinically assessed to determine if histological remission, measured by Eos/hpf, was induced under this diet for children with EOE
1 secondary outcome
Correlate esophageal counts with age of participant as a predictor of response
Time frame: 1 year
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 Jun 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. This study is not recruiting at the moment.
Joshua B Wechsler, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 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 United States. 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?
Demonstrate the efficacy of the empiric single food elimination diet of eliminating cows milk (time frame: 1 year). 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 Jun 2026.