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

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04941742
• Other study ID #: HSC-MS-18-1019 (validation)
• Status: Recruiting
• Start date: September 22, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: Tu T Mai, MD
• Phone: (713) 500-5663
• Email: noeoehouston[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Esophageal eosinophil counts as assessed by biopsy		baseline (day of first endoscopy)
Secondary	Esophageal eosinophil counts as assessed by biopsy		at about 4-12 weeks (day of second endoscopy)
Secondary	Blood eosinophil counts as assessed by complete blood count (CBC)		baseline (day of first endoscopy)
Secondary	Blood eosinophil counts as assessed by complete blood count (CBC)		at about 4-12 weeks (day of second endoscopy)
Secondary	Plasma beta-alanine level as assessed by high-performance liquid chromatography		baseline (day of first endoscopy)
Secondary	Plasma beta-alanine level as assessed by high-performance liquid chromatography		at about 4-12 weeks (day of second endoscopy)
Secondary	Plasma citrulline level as assessed by high-performance liquid chromatography		baseline (day of first endoscopy)
Secondary	Plasma citrulline level as assessed by high-performance liquid chromatography		at about 4-12 weeks (day of second endoscopy)