Baked Milk for Eosinophilic Esophagitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Topical steroids

Disqualifiers: Crohn's, Churg-Strauss, achalasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

26 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used topical swallowed steroids within 8 weeks before joining the study.

What data supports the effectiveness of the treatment Baked Milk for Eosinophilic Esophagitis?

Some studies suggest that introducing baked milk into the diet may help resolve milk allergies, and there is a case where a young boy with milk-triggered eosinophilic esophagitis (EoE) remained in remission after a baked milk challenge. However, more research is needed to confirm its effectiveness for EoE specifically. ^{1 2 3 4 5}

Is baked milk safe for humans, especially in the context of eosinophilic esophagitis or milk allergies?

Baked milk is generally safe for most children with cow's milk allergies, as many can tolerate it and it may help them outgrow their allergy faster. However, in the context of eosinophilic esophagitis, some cases may require a strict cow's milk-free diet for remission, and more studies are needed to fully understand its safety and effectiveness in this condition. ^{1 2 3 6 7}

How does the baked milk treatment for eosinophilic esophagitis differ from other treatments?

Baked milk treatment for eosinophilic esophagitis is unique because it involves consuming baked milk products instead of completely eliminating cow's milk, which is a common trigger for the condition. This approach is different from standard treatments like strict elimination diets or medications, as it aims to maintain some level of milk exposure to potentially build tolerance while still managing symptoms. ^{1 2 8 9 10}

Research Team

Karthik Ravi, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Eosinophilic esophagitis with a high eosinophil count.

Going through or completed the six-food elimination diet, with milk only or milk plus one additional food identified as a trigger

Exclusion Criteria

I have not used swallowed steroid treatments in the last 8 weeks.

Inability to read due to blindness, cognitive dysfunction, or English language illiteracy

I have a condition like Crohn's or Churg-Strauss that affects my esophagus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive baked milk in their diet to assess tolerance and remission over a 6-week period

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Baked Milk

Trial Overview 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.

Participant Groups

Group I: Baked Milk Experimental Treatment 1 Intervention

Baked milk introduction into diet

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Tolerance of Baked Cheese in Cow's Milk-Mediated Eosinophilic Esophagitis. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

Is a strict cow's milk-free diet necessary to treat milk oral immunotherapy-related eosinophilic esophagitis? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up After Baked Milk Introduction. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of six-food elimination diet on clinical and histologic outcomes in eosinophilic esophagitis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prospective, comparative effectiveness trial of cow's milk elimination and swallowed fluticasone for pediatric eosinophilic esophagitis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary baked milk accelerates the resolution of cow's milk allergy in children. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Role of Baked Egg and Milk in the Diets of Allergic Children. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Eosinophilic Esophagitis Occurring After Switching to Ultra-Pasteurized Milk: Coincidence or Unrecognized Etiologic Trigger? [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Identification of specific foods responsible for inflammation in children with eosinophilic esophagitis successfully treated with empiric elimination diet. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Liberalized Versus Strict Cow's Milk Elimination for the Treatment of Children with Eosinophilic Esophagitis. [2022]