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

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.

Study Overview

• Status: Completed
• Conditions: Eosinophilic Esophagitis

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients will be recruited from the outpatient clinic of the Pediatric Gastroenterology Division of The University of Texas Health and Science Center at Houston.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Active eosinophilic esophagitis
Eosinophilic esophagitis in remission
No eosinophilic esophagitis

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2019
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (ACTUAL): January 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: HSC-MS-18-1019 (pilot)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No