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N/A

Baked Milk for Eosinophilic Esophagitis

N/A
Waitlist Available
Led By Karthik Ravi, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if some milk-triggered EoE patients can eat baked milk & if they can tolerate small amounts of milk.

Who is the study for?
This trial is for individuals diagnosed with Eosinophilic Esophagitis (EoE) who have at least 15 eosinophils per HPF. Participants should be on or have completed a six-food elimination diet identifying milk as a trigger, alone or with one other food. It's not open to those with certain conditions like Crohn's disease, using topical swallowed steroids recently, or unable to read due to blindness, cognitive issues, or English illiteracy.
What is being tested?
The study aims to determine if people with milk-triggered EoE can tolerate baked milk in their diets and identify if there is an amount of straight milk they can handle without adverse effects.
What are the potential side effects?
While the trial description does not specify side effects, introducing baked milk could potentially cause allergic reactions or gastrointestinal symptoms in participants sensitive to it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Histological remission
Secondary study objectives
Symptomatic remission

Side effects data

From 2014 Phase 2 trial • 170 Patients • NCT00778258
80%
Food allergy
60%
Milk allergy
60%
Asthma
20%
Gastroenteritis viral
20%
Upper respiratory tract infection
20%
Eczema
20%
Seasonal allergy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Escalation - Reacted to Rice Pudding
Maintenance - Reacted to Pizza
Maintenance - Reacted to Non-baked Milk
Non-Randomized - Tolerant to Baked and Non-baked Milk
Dose Escalation - Reacted to Pizza
Dose Escalation - Reacted to Non-baked Milk
Maintenance - Reacted to Rice Pudding
Not Randomized - Comparison
Non-Randomized - Reacted to Muffin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Baked MilkExperimental Treatment1 Intervention
Baked milk introduction into diet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baked Milk
2008
Completed Phase 2
~490

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,119 Total Patients Enrolled
25 Trials studying Eosinophilic Esophagitis
1,465 Patients Enrolled for Eosinophilic Esophagitis
Karthik Ravi, MDPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
33 Total Patients Enrolled
2 Trials studying Eosinophilic Esophagitis
33 Patients Enrolled for Eosinophilic Esophagitis
~0 spots leftby Dec 2024
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