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OpenTrials
Active, Not Recruiting

NCT Number: NCT05083156

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ann & Robert H Lurie Childjren's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet Change

Other

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

Primary outcomes

  1. Demonstrate the efficacy of the empiric single food elimination diet of eliminating cows milk

    Time frame: 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 outcomes

  1. Correlate esophageal counts with age of participant as a predictor of response

    Time frame: 1 year

    Participant ages will be used in statistical analysis with eosinophil counts to determine if age is a predictor of response to treatment

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2027
First posted
Oct 19, 2021
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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