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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03812575

Enrollment

Registered

2019-01-23

Start date

2019-01-31

Completion date

2020-06-01

Last updated

2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Fractionated exhaled nitric oxide (FeNO) level	baseline (day of first endoscopy)	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.

Secondary

Measure	Time frame	Description
Esophageal eosinophil counts as assessed by biopsy	baseline (day of first 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	baseline (day of first endoscopy)	The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms.

Countries

United States

Outcome results