Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE)

NCT ID: NCT01929824

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-09-25

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Eosinophilic Esophagitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Oral Nitric Oxide testing

o Oral nitric oxide is measured by a breathing test where the participant will be seated in a chair and asked to breathe out into a small hand-held instrument for about 6 seconds.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Vivek N Iyer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vivek Iyer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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13-001194

Identifier Type: -

Identifier Source: org_study_id

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