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Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT01929824
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Vivek N Iyer, Mayo Clinic

Study Description
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Brief 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).

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Other: Oral Nitric Oxide testing

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis.
Actual Study Start Date : August 2013
Actual Primary Completion Date : September 25, 2017
Actual Study Completion Date : September 25, 2019

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Groups and Cohorts
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Intervention Details:
  • Other: 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.

Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with increase in Oral Nitric Oxide levels [ Time Frame: one year ]
    To determine if oral NO correlates to activity of disease in EoE


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with eosinophilic esophagitis
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929824


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Vivek Iyer, MD Mayo Clinic
More Information
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Responsible Party: Vivek N Iyer, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01929824    
Other Study ID Numbers: 13-001194
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vivek N Iyer, Mayo Clinic:
dysphagia, trouble swallowing, chest pain
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents