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

The University of Texas System (UT)

Status: Completed

Conditions: Eosinophilic Esophagitis

Study type: Observational

Funder types: Other

Identifiers

NCT03812575

HSC-MS-18-1019 (pilot)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 3 patient groups

Active eosinophilic esophagitis

Eosinophilic esophagitis in remission

No eosinophilic esophagitis