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Completed

NCT Number: NCT04941742

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

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.

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Key information

Conditions

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

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fractionated exhaled nitric oxide (FeNO) level

    Time frame: baseline (day of first endoscopy)

    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.

  2. Fractionated exhaled nitric oxide (FeNO) level

    Time frame: at about 4-12 weeks (day of second endoscopy)

    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.

Secondary outcomes

  1. Esophageal eosinophil counts as assessed by biopsy

    Time frame: baseline (day of first endoscopy)

  2. Esophageal eosinophil counts as assessed by biopsy

    Time frame: at about 4-12 weeks (day of second endoscopy)

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

    Time frame: baseline (day of first endoscopy)

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

    Time frame: at about 4-12 weeks (day of second endoscopy)

  5. Plasma beta-alanine level as assessed by high-performance liquid chromatography

    Time frame: baseline (day of first endoscopy)

  6. Plasma beta-alanine level as assessed by high-performance liquid chromatography

    Time frame: at about 4-12 weeks (day of second endoscopy)

  7. Plasma citrulline level as assessed by high-performance liquid chromatography

    Time frame: baseline (day of first endoscopy)

  8. Plasma citrulline level as assessed by high-performance liquid chromatography

    Time frame: at about 4-12 weeks (day of second endoscopy)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2021
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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