Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis

Active, not recruiting

• Conditions: Eosinophilic Esophagitis

• Registration Number: NCT05083156
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

The investigators seek to assess the efficacy of removing cow's milk from an EoE patient's diet. This will be determined by esophageal inflammation and clinical and histological response to the milk elimination treatment.

Detailed Description

The dietary approach is based on the hypothesis that food antigen(s) trigger eosinophilic inflammation and clinical and histological remission can be induced by identifying and excluding the causative food antigen(s). It is believed that eliminating causative food antigen(s) target the cause and thus induces long term remission.

This process is difficult as it requires multiple, invasive endoscopies and introduces the possibility of iatrogenic effects such as nutrient deficiency due to simultaneous multiple food eliminations. In addition, patient compliance may be compromised, both intentionally and unintentionally as many families report the elimination process to be both confusing and frustrating.

This prospective study eliminating only cow's milk proteins, which are a common cause of esophageal inflammation in patients with eosinophilic esophagitis, will assess the histological response in a cohort of children receiving care at Lurie Children's.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2017-04
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-18
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate the efficacy of the empiric single food elimination diet of eliminating cows milk	1 year	Participants who have eliminated cow's milk will be clinically assessed to determine if histological remission, measured by Eos/hpf, was induced under this diet for children with EOE

Secondary Outcome Measures

Name	Time	Method
Correlate esophageal counts with age of participant as a predictor of response	1 year	Participant ages will be used in statistical analysis with eosinophil counts to determine if age is a predictor of response to treatment

Trial Locations

Locations (1)

Ann & Robert H Lurie Childjren's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States