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CompletedNCT01929824Updated Sep 30, 2019

Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE)

An observational study in Eosinophilic Esophagitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • dysphagia, trouble swallowing, chest pain
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In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 91 observational studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with eosinophilic esophagitis

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

Exclusion criteria:

  • Subjects with chronic cough
  • Severe CAD
  • MI within the last 3 months
  • Cystic fibrosis
  • Tuberculosis
  • Chronic obstructive pulmonary disease (COPD)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • OtherOral 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.

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What researchers measure

Primary outcomes

  1. Number of patients with increase in Oral Nitric Oxide levels

    To determine if oral NO correlates to activity of disease in EoE

    Time frame: one year

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Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01929824
Lead sponsor
Mayo Clinic
Responsible party
Vivek N Iyer (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Aug 28, 2013
Start date
Aug 2013
Primary completion
Sep 25, 2017
Completion
Sep 25, 2019
Last update
Sep 30, 2019

Study contacts

Vivek Iyer, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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