Eosinophilic EsophagitisNCT05606705
A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis
A study testing Baked Milk in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to see if patients with milk-triggered EoE are able to tolerate baked milk in their diet and if there is a threshold amount of straight milk that is tolerable. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Baked Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2022to 22 Dec 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Eosinophilic esophagitis ≥ 15 eosinophils per HPF
- Going through or completed the six-food elimination diet, with milk only or milk plus one additional food identified as a trigger
Who cannot join
- Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
- Topical swallowed steroids within 8 weeks of study enrollment
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of Baked Milk Introduction in Patients With Milk-triggered Eosinophilic Esophagitis
This research is being done to see if patients with milk-triggered EoE are able to tolerate baked milk in their diet and if there is a threshold amount of straight milk that is tolerable.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Baked Milk
- 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 MilkDietary supplement
Participants to regularly eat a baked milk muffin for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Baked Milk | Experimental | Baked milk introduction into diet Receives: Dietary Supplement: Baked Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological remission
Number of patients in histologic remission at the end of a 6 week trial of baked milk. Histologic remission is defined by <15 eos per HPF on cytosponge.
Measured: 6 weeks
Secondary outcomes (1)
Symptomatic remission
Number of patients in symptomatic remission after a 6 week trial of baked milk. Symptomatic remission is defined by EEsAI PRO score of <20
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start5 Dec 2022
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
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 Mayo ClinicThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Ravi, M.D., Mayo Clinic
- Investigators
- Karthik Ravi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606705
- Sponsor's protocol ID
- 22-007941
- Status last verified
- Jan 2026
- First submitted
- 31 Oct 2022
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Baked Milk Introduction in Patients With Milk-triggered Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT05606705
- Acronym / sponsor ID
- 22-007941
- Conditions
- Eosinophilic Esophagitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 7 Nov 2022 (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.
This research is being done to see if patients with milk-triggered EoE are able to tolerate baked milk in their diet and if there is a threshold amount of straight milk that is tolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baked Milk | Experimental | Dietary Supplement: Baked MilkBaked milk introduction into diet |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with Eosinophilic esophagitis ≥ 15 eosinophils per HPF
- Going through or completed the six-food elimination diet, with milk only or milk plus one additional food identified as a trigger
Key exclusion criteria (3 listed)
- Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
- Topical swallowed steroids within 8 weeks of study enrollment
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
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 MilkParticipants to regularly eat a baked milk muffin for 6 weeks | Dietary supplement | Baked Milk |
Primary outcome
Histological remission
Time frame: 6 weeks
Number of patients in histologic remission at the end of a 6 week trial of baked milk. Histologic remission is defined by <15 eos per HPF on cytosponge.
1 secondary outcome
Symptomatic remission
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Karthik Ravi, MD principal investigator
Mayo Clinic
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 in people with Eosinophilic Esophagitis, run by Mayo Clinic 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 2 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: finished, as of the sponsor's last update on 9 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histological remission (time frame: 6 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 9 Jan 2026.