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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 5 Years - 18 Years
Gender All
More Inclusion & Exclusion 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 VERO®" (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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03812575
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The University of Texas Health Science Center, Houston
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tu T Mai, MD
Principal Investigator Affiliation The University of Texas Health Science Center, Houston
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Arms & Interventions

Arms

: Active eosinophilic esophagitis

: Eosinophilic esophagitis in remission

: No eosinophilic esophagitis

Interventions

Contact a Trial Team

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Houston, Texas

Status

Recruiting

Address

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

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