The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Pilot)

Study Overview
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Brief Summary
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The purpose of the study is to evaluate of the relationships between fractionated exhaled nitric oxide, disease activity, and symptom severity in patients with eosinophilic esophagitis compared to those without eosinophilic esophagitis.

Official Title
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The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patient who will undergo esophagogastroduodenoscopy with biopsies at Children's Memorial Hermann Hospital, as part of the standard of care in the evaluation of EoE Able to perform the single-breath exhalation for the hand-held analyzer, NIOX MINO (Aerocrine, Sweden) Signed informed consent by a parent or legal guardian Signed assent form by the child/adolescent subjects 7-18 years of age Exclusion Criteria: Past medical history of asthma, allergic rhinitis, IBD, parasitic infection, hay fever and any exposure to smoking (including secondhand smoke) because these disorders are known to affect the FeNO levels Active respiratory tract infections at the time of FeNO evaluation because this can affect the result of the FeNO as well Asthma questionnaire and/or Spirometry test consistent with asthma

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active eosinophilic esophagitis<br> | |
| Eosinophilic esophagitis in remission<br> | |
| No eosinophilic esophagitis<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractionated exhaled nitric oxide (FeNO) level | The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor. | baseline (day of first endoscopy) | 
| Fractionated exhaled nitric oxide (FeNO) level | The FeNO measurement will be performed using a hand-held analyzer, the NIOX MINO (Aerocrine, Sweden). During this non-invasive procedure the patient is asked to perform a 4-6 second single-breath exhalation into the NIOX MINO, which measures FeNO in 100s with an electrochemical sensor. | at about 4-12 weeks (day of second endoscopy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal eosinophil counts as assessed by biopsy |  | baseline (day of first endoscopy) | 
| Esophageal eosinophil counts as assessed by biopsy |  | at about 4-12 weeks (day of second endoscopy) | 
| Serum eosinophil counts as assessed by complete blood count (CBC) |  | baseline (day of first endoscopy) | 
| Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire | The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. | baseline (day of first endoscopy) | 
| Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire | The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. | at about 4-12 weeks (day of second endoscopy) |