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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Histological remission

Secondary outcome measures

Symptomatic remission

Side effects data

From 2014 Phase 2 trial • 170 Patients • NCT00778258

93%

Food allergy

80%

Milk allergy

33%

Upper respiratory tract infection

27%

Eczema

20%

Rhinitis allergic

20%

Gastroenteritis viral

20%

Asthma

13%

Urticaria

13%

Nasal congestion

Seasonal allergy

Gastrointestinal viral infection

Wrist fracture

Diarrhoea

Rhinorrhoea

Sneezing

Growth hormone deficiency

Abdominal pain upper

Rectal prolapse

Ear infection

Influenza

Pharyngitis streptococcal

Pneumonia

Seizure

Haematochezia

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance - Reacted to Pizza

Dose Escalation - Reacted to Rice Pudding

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,227 Previous Clinical Trials

3,771,642 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limitation for this medical experiment restricted to those 18 and over?

"For this research study, individuals aged 18 to 90 years old can submit their applications for consideration."

Answered by AI

Could I register for the investigation?

"This research is searching for 26 individuals with eosinophilic esophagitis who are between 18 and 90 years of age. Candidates must demonstrate a diagnosis of Eosinophilic esophagitis ≥ 15 eosinophils per HPF, the successful or attempted completion of a six-food elimination diet that identifies milk as well as one other trigger food."

Answered by AI

Are there presently opportunities to join this experiment?

"As per the information hosted on clinicaltrials.gov, this trial is not accepting applications currently; its initial posting was November 1st 2022 and most recent update occurred October 31st 2022. Despite that, there are 53 other medical studies actively looking for participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis

Karthik Ravi, M.D. 2022. "A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05606705.

All > Eosinophilic Esophagitis