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

NCT04941742 | Completed

• 1 other identifier: HSC-MS-18-1019 (validation)
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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)

• Blood eosinophil counts as assessed by complete blood count (CBC)

  baseline (day of first endoscopy)

• 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

  baseline (day of first endoscopy)

Study Arms (3)

Active eosinophilic esophagitis

Eosinophilic esophagitis in remission

No eosinophilic esophagitis

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related 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 Nutr. 2023 Jan 1;76(1):59-65. doi: 10.1097/MPG.0000000000003634. Epub 2022 Oct 11.

  PMID: 36574003 RESULT

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tu T Mai, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 28, 2021
• Study Start: September 22, 2020
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)