Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis

NCT ID: NCT05083156

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2025-12-31

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.

Conditions

Eosinophilic Esophagitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Milk Elimination

cohort will be observed for treatment response to elimination of cow's milk

Diet Change

Intervention Type: OTHER

Observation Cohort will be observed for treatment response to elimination of cow's milk

Interventions

Diet Change

Observation Cohort will be observed for treatment response to elimination of cow's milk

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Joshua Wechsler

Attending Physician, Gatroenterology, Hepatology & Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua B Wechsler, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann & Robert H Lurie Childjren's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2012-14865

Identifier Type: -

Identifier Source: org_study_id