A Study of Baked Milk Tolerance to Treat Eosinophilic Eso... | NCT05606705

Studies
A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis

NCT05606705

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 9, 2026Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Eosinophilic Esophagitis

Interventions

Baked Milk

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2022Actual

Primary Completion Date

Dec 22, 2025Actual

Completion Date

Dec 22, 2025Actual

First Submitted Date

Oct 31, 2022

First Submission Date that Met QC Criteria

Oct 31, 2022

First Posted Date

Nov 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2026

Last Update Posted Date

Jan 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Baked Milk	Experimental	Baked milk introduction into diet	Dietary Supplement: Baked Milk

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baked Milk	Dietary Supplement	Participants to regularly eat a baked milk muffin for 6 weeks	Baked Milk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	6 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karthik Ravi, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Minnesota		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 26, 2023	Jan 6, 2026	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D057765	Eosinophilic Esophagitis

Ancestor Terms

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided