The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Fractionated exhaled nitric oxide (FeNO) level
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Fractionated exhaled nitric oxide (FeNO) level
时间窗: 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.
次要结局
- Blood eosinophil counts as assessed by complete blood count (CBC)(at about 4-12 weeks (day of second endoscopy))
- Esophageal eosinophil counts as assessed by biopsy(at about 4-12 weeks (day of second endoscopy))
- Plasma citrulline level as assessed by high-performance liquid chromatography(at about 4-12 weeks (day of second endoscopy))
- Plasma beta-alanine level as assessed by high-performance liquid chromatography(at about 4-12 weeks (day of second endoscopy))
研究者
Tu Thanh Mai
Assistant Professor
The University of Texas Health Science Center, Houston