NCT05606705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

October 31, 2022

Last Update Submit

January 7, 2026

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Symptomatic remission

    6 weeks

Study Arms (1)

Baked Milk

EXPERIMENTAL

Baked milk introduction into diet

Dietary Supplement: Baked Milk

Interventions

Baked MilkDIETARY_SUPPLEMENT

Participants to regularly eat a baked milk muffin for 6 weeks

Baked Milk

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Karthik Ravi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 7, 2022

Study Start

December 5, 2022

Primary Completion

December 22, 2025

Study Completion

December 22, 2025

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)