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OpenTrials
Completed

NCT Number: NCT05606705

A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis

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.

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baked Milk

Dietary Supplement

Participants to regularly eat a baked milk muffin for 6 weeks

Primary outcomes

  1. Histological remission

    Time frame: 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 outcomes

  1. Symptomatic remission

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2022
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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