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

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

NCT04941742

Enrollment

Registered

2021-06-28

Start date

2020-09-22

Completion date

2021-12-22

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 this study is to evaluate the relationship between fractionated exhaled nitric oxide, peripheral eosinophils, and plasma citrulline and ß-alanine in patients with eosinophilic esophagitis (EoE) compared to those without EoE. The hypothesis is that a combination of elevated fractional exhaled nitric oxide, increased peripheral eosinophils, and elevated plasma citrulline and ß-alanine is associated with active EoE.

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, ages 5-18 years old, who will undergo esophagogastroduodenoscopy with biopsies at Children's Memorial Hermann Hospital, as part of the standard of care in the evaluation of EoE * 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 active asthma, active allergic rhinitis, inflammatory bowel disease (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
Esophageal eosinophil counts as assessed by biopsy	baseline (day of first endoscopy)
Blood eosinophil counts as assessed by complete blood count (CBC)	baseline (day of first endoscopy)
Plasma beta-alanine level as assessed by high-performance liquid chromatography	baseline (day of first endoscopy)
Plasma citrulline level as assessed by high-performance liquid chromatography	baseline (day of first endoscopy)

Countries

United States

Outcome results