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NCT05606705 Clinical Trial

A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05606705
Other study ID # 22-007941
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 5, 2022
Est. completion date December 2024

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 26
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Baked Milk
Participants to regularly eat a baked milk muffin for 6 weeks

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Symptomatic remission Number of patients in symptomatic remission after a 6 week trial of baked milk. Symptomatic remission is defined by EEsAI PRO score of <20 6 weeks
See also
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Completed NCT03633617 - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) Phase 3
Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Completed NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
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Completed NCT05084963 - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis Phase 2
Completed NCT02579876 - Milk Patch for Eosinophilic Esophagitis Phase 2
Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population

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