Back to resultsA Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis
Primary Purpose
Eosinophilic Esophagitis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baked Milk
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Baked Milk
Arm Description
Baked milk introduction into diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05606705
Brief Title
A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis
Official Title
A Pilot Trial of Baked Milk Introduction in Patients With Milk-triggered Eosinophilic Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baked Milk
Arm Type
Experimental
Arm Description
Baked milk introduction into diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Baked Milk
Intervention Description
Participants to regularly eat a baked milk muffin for 6 weeks
Primary Outcome Measure Information:
Title
Histological remission
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Symptomatic remission
Description
Number of patients in symptomatic remission after a 6 week trial of baked milk. Symptomatic remission is defined by EEsAI PRO score of <20
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthik Ravi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis
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