Clinical trial NCT04941742: The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Official title: The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 71
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fractionated exhaled nitric oxide (FeNO) level
timeFrame: baseline (day of first endoscopy)
measure: Fractionated exhaled nitric oxide (FeNO) level
timeFrame: at about 4-12 weeks (day of second endoscopy)
Secondary outcomes:
measure: Esophageal eosinophil counts as assessed by biopsy
timeFrame: baseline (day of first endoscopy)
measure: Esophageal eosinophil counts as assessed by biopsy
timeFrame: at about 4-12 weeks (day of second endoscopy)
measure: Blood eosinophil counts as assessed by complete blood count (CBC)
timeFrame: baseline (day of first endoscopy)
measure: Blood eosinophil counts as assessed by complete blood count (CBC)
timeFrame: at about 4-12 weeks (day of second endoscopy)
measure: Plasma beta-alanine level as assessed by high-performance liquid chromatography
timeFrame: baseline (day of first endoscopy)
measure: Plasma beta-alanine level as assessed by high-performance liquid chromatography
timeFrame: at about 4-12 weeks (day of second endoscopy)
measure: Plasma citrulline level as assessed by high-performance liquid chromatography
timeFrame: baseline (day of first endoscopy)
measure: Plasma citrulline level as assessed by high-performance liquid chromatography
timeFrame: at about 4-12 weeks (day of second endoscopy)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Tu T Mai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.