Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Other: Diet Change

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 Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Childjren's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The sample size was determined based on the one-proportion non-inferiority test. The investigators recruited 54 subjects throughout the recruitment period.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Milk Elimination; cohort will be observed for treatment response to elimination of cow's milk	Other: Diet Change; Observation Cohort will be observed for treatment response to elimination of cow's milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the efficacy of the empiric single food elimination diet of eliminating cows milk	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	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Joshua B Wechsler, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): April 1, 2017
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Eosinophilic Esophagitis
• Other Study ID Numbers: 2012-14865

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No