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

Completed

• Conditions: Eosinophilic Esophagitis

• Registration Number: NCT04941742
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-28
• Primary Completion: 2021-12-22
• Study Completion: 2021-12-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fractionated exhaled nitric oxide (FeNO) level	at about 4-12 weeks (day of second 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 Outcome Measures

Name	Time	Method
Blood eosinophil counts as assessed by complete blood count (CBC)	at about 4-12 weeks (day of second endoscopy)
Plasma beta-alanine level as assessed by high-performance liquid chromatography	at about 4-12 weeks (day of second endoscopy)
Esophageal eosinophil counts as assessed by biopsy	at about 4-12 weeks (day of second endoscopy)
Plasma citrulline level as assessed by high-performance liquid chromatography	at about 4-12 weeks (day of second endoscopy)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States