Could ditching milk soothe a painful esophagus? new trial tests Diet-Only approach
NCT ID NCT05083156
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether simply removing cow's milk from the diet can control eosinophilic esophagitis (EoE) in children aged 1 to 18. EoE is a condition where the esophagus becomes inflamed, often causing trouble swallowing. The trial will check if this diet change leads to less inflammation and better symptoms. Fifty-four children are taking part, and researchers will also see if age affects how well the diet works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Diet change: elimination of cow's milk
- What this could lead to
- If it works, this could offer a simple dietary approach to control eosinophilic esophagitis in children, reducing the need for medications.
- What could go wrong
- This is a small, early-stage study with only 54 participants. The diet may not work for everyone, and it can be hard to follow long-term. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
54 people
The number who actually took part.
- Started
-
Mar 2012
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The sample size was determined based on the one-proportion non-inferiority test. The investigators recruited 54 subjects throughout the recruitment period.
- Ages
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1 year to 18 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged 1-18 * Patients who meet the criteria for diagnosis of EoE with ≥15 eosinophils per high power field and who had been previously treated with an adequate dose of PPI for 6-8 weeks or had a normal 24 hour ph probe study will be recruited from the patients seen by one of the physicians in the EoE clinic at Lurie Children's and other participating centers * Patients who agree to cow's milk elimination diet as their treatment of EoE Exclusion Criteria: * Patients who started on oral or swallowed steroids (prior use of steroids that was discontinued more than two months prior to enrollment does not constitute an exclusion criterion) * Patients who are unable to tolerate the cow's milk elimination diet * Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ann & Robert H Lurie Childjren's Hospital of Chicago
Chicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Swallowable sponge could replace endoscopy for esophagitis monitoring
- Blood tests may replace scopes for EoE diagnosis
- Massive new registry aims to crack the code on mysterious gut disorders
- 300 kids with EoE enrolled in landmark database study
- Can cutting four foods ease Kids' esophagus inflammation?