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

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

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.

Study Overview

• Status: Completed
• Conditions: Eosinophilic Esophagitis

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Active eosinophilic esophagitis
Eosinophilic esophagitis in remission
No eosinophilic esophagitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
Plasma beta-alanine level as assessed by high-performance liquid chromatography	at about 4-12 weeks (day of second endoscopy)
Plasma citrulline level as assessed by high-performance liquid chromatography	baseline (day of first endoscopy)
Plasma citrulline level as assessed by high-performance liquid chromatography	at about 4-12 weeks (day of second endoscopy)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Tu T Mai, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): December 22, 2021
• Study Completion (Actual): December 22, 2021

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: HSC-MS-18-1019 (validation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No