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Nasal Nitric Oxide Levels in EoE

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vivek N Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01929824
First received: August 14, 2013
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
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 Intervention
Eosinophilic Esophagitis Other: Oral Nitric Oxide testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis.

Resource links provided by NLM:


Further study details as provided by Vivek N Iyer, Mayo Clinic:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929824

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Vivek Iyer, MD Mayo Clinic
  More Information

Responsible Party: Vivek N Iyer, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01929824     History of Changes
Other Study ID Numbers: 13-001194
Study First Received: August 14, 2013
Last Updated: September 12, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Vivek N Iyer, Mayo Clinic:
dysphagia, trouble swallowing, chest pain

Additional relevant MeSH terms:
Eosinophilic Esophagitis
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

ClinicalTrials.gov processed this record on June 26, 2017