Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis

NCT05083156 | Active Not Recruiting

• 1 other identifier: 2012-14865
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlate esophageal counts with age of participant as a predictor of response

  1 year

Study Arms (1)

Milk Elimination

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

Other: Diet Change

Interventions

Diet Change OTHER

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

Milk Elimination

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who are unable to tolerate the cow's milk elimination diet
• Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Childjren's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Intestinal Biopsies in AllProtect or RNAlater 2. Whole Blood/Plasma/Serum

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Joshua B Wechsler, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Gatroenterology, Hepatology & Nutrition

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: March 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)