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
| Type | Name | Description |
|---|---|---|
| OTHER | Diet Change | Observation 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.