Baked Milk for Eosinophilic Esophagitis

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if individuals with eosinophilic esophagitis (EoE), an inflammatory condition of the esophagus often triggered by foods like milk, can tolerate baked milk in their diet. Researchers seek to identify an amount of regular milk that patients can consume without triggering symptoms. The trial targets those with milk-triggered EoE who have completed or are undergoing a special diet to identify food triggers and have not recently used certain medications. As an unphased trial, it offers participants the chance to contribute to understanding dietary management for EoE.

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 prior data suggests that baked milk is safe for patients with milk-triggered EoE?

Research has shown that baked milk might be safe for people with milk-triggered eosinophilic esophagitis (EoE), a condition where milk causes throat inflammation. One study found that some individuals could consume baked milk without issues. In another study, 33% of participants experienced reactions after trying baked milk. Most reactions were mild, but some were severe. However, many people successfully included baked milk in their diet without major issues.

Other findings suggest that people with EoE might also tolerate small amounts of regular dairy, indicating that baked milk could be a safer option than raw milk. Overall, while some negative reactions can occur, baked milk is generally well-tolerated by many with milk-triggered EoE.12345

Why are researchers excited about this trial?

Baked milk is unique because it introduces a potential dietary approach to managing eosinophilic esophagitis, a condition typically treated with dietary elimination, steroids, or proton pump inhibitors. Unlike these standard treatments, baked milk involves gradually incorporating milk that has been cooked at high temperatures, which can alter the milk proteins and potentially reduce allergic reactions. Researchers are excited about this approach as it may help patients build tolerance to milk, possibly offering a more natural and less medication-reliant strategy for managing their condition.

What evidence suggests that baked milk might be an effective treatment for EoE?

Research has shown that people with milk-triggered eosinophilic esophagitis (EoE) might be able to include baked milk in their diet. In one study, participants who consumed baked milk had fewer eosinophils, the cells responsible for inflammation, in their esophagus. Another study found that some people with EoE could tolerate not only baked milk but also small amounts of regular dairy. Baked milk might be easier to handle because heating alters the proteins, reducing the likelihood of a reaction. This trial will specifically evaluate the introduction of baked milk into the diet of participants with milk-triggered EoE. Overall, these findings suggest that baked milk could be a promising option for those with milk-triggered EoE.23467

Who Is on the Research Team?

KR

Karthik Ravi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Baked MilkExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Tolerance of baked milk in patients with cow's ...Within this group, we identified 16 patients with definitive EoE who ingested sufficient baked milk products for at least 6 weeks. Data for only 15 patients ...
S475 Baked Milk and Small Quantity Straight Milk Is...These findings suggest that patients with milk-triggered EoE may be able to tolerate baked milk and small amounts of dairy in their diet.
Tolerability of Baked Dairy Protein in Eosinophilic ...Some patients tolerate baked dairy products, which are less allergenic due to denaturation of proteins through heat. The potential for baked dairy to be ...
Liberalized Versus Strict Cow's Milk Elimination for the ...In summary, 77% of patients were found to have some degree of decreased esophageal eosinophils in response to CME, with 58% achieving histological remission ...
Long-Term Follow-Up After Baked Milk IntroductionAfter a median of 49 months of follow-up, 43% of the 187 had progressed to direct milk, 20% to less-cooked forms of milk, 10% remained ingesting BM, and 28% ...
Long-term Follow up After Baked Milk Introduction - PMCThere were 79 reported milk reactions involving 68 patients (33% of total) during follow-up. Of these, 78% were classified as mild, 14% severe, and 6 patients ...
Small Study Indicates Adults With EoE Can Tolerate ...One-year follow-up data were available for 10 patients who successfully tolerated sterilized milk and maintained remission; they also consumed ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security