Overview

This trial is active, not recruiting.

Condition eosinophilic esophagitis
Treatment oral nitric oxide testing
Sponsor Mayo Clinic
Start date August 2013
End date December 2016
Trial size 50 participants
Trial identifier NCT01929824, 13-001194

Summary

This study is aimed at understanding whether oral nitric oxide levels can be used as a non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis (EoE).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Number of patients with increase in Oral Nitric Oxide levels
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Subjects with dysphagia and active esophageal infiltration (esophageal eosinophilic count of >/= 15 eos/hpf) - Subjects with or without a clinical diagnosis of asthma Exclusion criteria: - Subjects with chronic cough - Severe CAD - MI within the last 3 months - Cystic fibrosis - Tuberculosis - Chronic obstructive pulmonary disease (COPD)

Additional Information

Official title A Pilot Study: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis.
Principal investigator Vivek Iyer, MD
Description Nitric oxide (NO) is produced by activated eosinophils and oral NO levels are known to be elevated in asthma and eosinophilic bronchitis. The measurement of oral NO is a non-invasive,easy to perform low cost procedure that is used frequently in the diagnosis and management of asthma. The diagnosis of eosinophilic esophagitis (EoE) requires conscious sedation, an upper endoscopy with biopsy, and histologic evaluation of the biopsy specimen. This is a costly and somewhat invasive procedure. If oral NO was elevated as a result of activity of esophageal eosinophils in EoE, the measurement of oral NO may potentially be a very convenient and useful test in the evaluation and treatment of EoE. We propose a pilot study to determine if oral NO levels are elevated in patients with eosinophilic esophagitis.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.