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

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: Completed

Administrative data

• NCT number: NCT03812575
• Other study ID #: HSC-MS-18-1019 (pilot)
• Status: Completed
• Start date: January 31, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

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, 

References & Publications (1)

Josyabhatla R, Abrenica C, Mai T, Hashmi SS, Liu Y, Mosquera R, Van Arsdall M, Navarro F, Tchakarov A, Tatevian N, Wu G, Rhoads JM. Plasma Biomarkers and Fractional Exhaled Nitric Oxide in the Diagnosis of Eosinophilic Esophagitis. J Pediatr Gastroenterol — View Citation

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	Serum eosinophil counts as assessed by complete blood count (CBC)		baseline (day of first endoscopy)
Secondary	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)
Secondary	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)