A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis
Not Applicable
Active, not recruiting
- Conditions
- Eosinophilic Esophagitis
- 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
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
Mayo Clinic Minnesota🇺🇸Rochester, Minnesota, United States