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A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis

A Pilot Trial of Baked Milk Introduction in Patients With Milk-triggered Eosinophilic Esophagitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05606705
Enrollment
7
Registered
2022-11-07
Start date
2022-12-05
Completion date
2025-12-22
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

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.

Interventions

DIETARY_SUPPLEMENTBaked Milk

Participants to regularly eat a baked milk muffin for 6 weeks

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Histological remission6 weeksNumber 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

MeasureTime frameDescription
Symptomatic remission6 weeksNumber of patients in symptomatic remission after a 6 week trial of baked milk. Symptomatic remission is defined by EEsAI PRO score of \<20

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026