A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05606705
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Karthik Ravi, MD
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Baked Milk

Baked milk introduction into diet

Interventions

Dietary Supplement: - Baked Milk

Participants to regularly eat a baked milk muffin for 6 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Minnesota, Rochester, Minnesota

Status

Address

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

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