A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis

January 7, 2026 updated by: Karthik Ravi, M.D., Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baked Milk
Baked milk introduction into diet
Dietary supplement: Baked Milk
Participants to regularly eat a baked milk muffin for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic remission
Time Frame: 6 weeks
Number of patients in symptomatic remission after a 6 week trial of baked milk. Symptomatic remission is defined by EEsAI PRO score of <20
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Karthik Ravi, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Actual)

December 22, 2025

Study Completion (Actual)

December 22, 2025

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-007941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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