Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT05083156

Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
54 (actual)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
Sex
All
Age
1 Year – 18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERDiet ChangeObservation Cohort will be observed for treatment response to elimination of cow's milk

Timeline

Start date
2012-03-01
Primary completion
2017-04-01
Completion
2025-12-01
First posted
2021-10-19
Last updated
2024-11-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05083156. Inclusion in this directory is not an endorsement.