A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis

Not Applicable

Active, not recruiting

• Conditions: Eosinophilic Esophagitis
• Interventions: Dietary Supplement: Baked Milk

• Registration Number: NCT05606705
• Lead Sponsor: Mayo Clinic

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-07
• Study Start: 2022-12-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baked Milk	Baked Milk	Baked milk introduction into diet

Primary Outcome Measures

Name	Time	Method
Histological remission	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.

Secondary Outcome Measures

Name	Time	Method
Symptomatic remission	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

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States