NCT03822325

Inflammatory Mediators as Potential Non-Invasive Biomarkers in Subjects With Eosinophilic Esophagitis

Inflammatory Mediators as Potential Non-Invasive Biomarkers and Understanding the Mechanism of Remodeling in Tissue Biopsies in Subjects With Eosinophilic Esophagitis: A Pilot Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 88 (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 esophageal inflammation or lack of it in response to treatment with a novel non-invasive method that would measure eosinophil-associated inflammatory mediators in the blood and urine to determine the presence of active Eosinophilic Esophagitis. For these purposes, the investigators will correlate esophageal inflammatory mediators measured in blood and urine with histological findings identified on esophageal mucosal biopsies. Additionally, biopsies associated mediators will be assessed relative to clinical phenotype and outcome.

Detailed description

The diagnosis, assessment of recurrence of inflammation, response to treatment and remission in EoE are all currently based on histological evaluation of upper endoscopic pinch esophageal biopsies. Obtaining biopsies for histological evaluation by this procedure is both invasive and expensive. The purpose of our longitudinal prospective study is to evaluate and quantify a panel of novel non-invasive eosinophilic inflammatory biomarkers in the blood and urine of subjects with EoE and compare their presence and levels with the presence or absence of measures of inflammation in esophageal biopsies. While evaluation of esophageal biopsies with 15 or more eosinophils per high power field is the gold standard for diagnosis of EoE, novel predictors of clinical outcome remain unclear. The objective is to identify one or more sensitive and specific non-invasive biomarkers that could be used to monitor esophageal inflammation, and identify novel tissue-based markers that identify phenotype and outcome. This would eliminate the need for invasive serial surveillance endoscopies for the purpose of evaluating for recurrence of inflammation or response to standard therapy since symptoms alone do not adequately correlate with either the presence or absence of disease activity (inflammation) in the esophagus of patients with EoE.

Conditions

• Eosinophilic Esophagitis

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-05-01
• Completion: 2025-11-01
• First posted: 2019-01-30
• Last updated: 2024-11-15

Locations

2 sites across 1 country: United States