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出境医 / 临床实验 / 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 (Validation Phase)

Study Description
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.


Condition or disease
Eosinophilic Esophagitis

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 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 : September 22, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022
Arms and Interventions
Group/Cohort
Active eosinophilic esophagitis
Eosinophilic esophagitis in remission
No eosinophilic esophagitis
Outcome Measures
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. 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) ]

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, 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
Contacts and Locations

Contacts
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Contact: Tu T Mai, MD (713) 500-5663 noeoehouston@gmail.com

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Tu T Mai, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Tu T Mai, MD The University of Texas Health Science Center, Houston
Tracking Information
First Submitted Date June 21, 2021
First Posted Date June 28, 2021
Last Update Posted Date October 12, 2021
Actual Study Start Date September 22, 2020
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2021)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 21, 2021)
  • Esophageal eosinophil counts as assessed by biopsy [ Time Frame: baseline (day of first endoscopy) ]
  • Esophageal eosinophil counts as assessed by biopsy [ Time Frame: at about 4-12 weeks (day of second endoscopy) ]
  • Blood eosinophil counts as assessed by complete blood count (CBC) [ Time Frame: baseline (day of first endoscopy) ]
  • Blood eosinophil counts as assessed by complete blood count (CBC) [ Time Frame: at about 4-12 weeks (day of second endoscopy) ]
  • Plasma beta-alanine level as assessed by high-performance liquid chromatography [ Time Frame: baseline (day of first endoscopy) ]
  • Plasma beta-alanine level as assessed by high-performance liquid chromatography [ Time Frame: at about 4-12 weeks (day of second endoscopy) ]
  • Plasma citrulline level as assessed by high-performance liquid chromatography [ Time Frame: baseline (day of first endoscopy) ]
  • Plasma citrulline level as assessed by high-performance liquid chromatography [ Time Frame: at about 4-12 weeks (day of second endoscopy) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Eosinophilic Esophagitis
Intervention Not Provided
Study Groups/Cohorts
  • Active eosinophilic esophagitis
  • Eosinophilic esophagitis in remission
  • No eosinophilic esophagitis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 21, 2021) 		60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tu T Mai, MD (713) 500-5663 noeoehouston@gmail.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04941742
Other Study ID Numbers HSC-MS-18-1019 (validation)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Tu Thanh Mai, The University of Texas Health Science Center, Houston
Study Sponsor The University of Texas Health Science Center, Houston
Collaborators Not Provided
Investigators
Principal Investigator: Tu T Mai, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date October 2021