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

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ClinicalTrials.gov Identifier: NCT03812575
Recruitment Status : Completed
First Posted : January 23, 2019
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Tu Thanh Mai, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
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.

Condition or disease
Eosinophilic Esophagitis

Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

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Groups and Cohorts
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Group/Cohort
Active eosinophilic esophagitis
Eosinophilic esophagitis in remission
No eosinophilic esophagitis


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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. Serum eosinophil counts as assessed by complete blood count (CBC) [ Time Frame: baseline (day of first endoscopy) ]
  4. Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire [ Time Frame: baseline (day of first endoscopy) ]
    The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms.

  5. Disease-related symptoms severity as assessed by Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) version 2.0 questionnaire [ Time Frame: at about 4-12 weeks (day of second endoscopy) ]
    The range of total score is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812575


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Tu T Mai, MD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Tu Thanh Mai, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03812575    
Other Study ID Numbers: HSC-MS-18-1019 (pilot)
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases