Clinical Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Number of Participants With Reported Adverse Events
研究概览
简要总结
Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
详细描述
Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be older than 3 and younger than 18 years of age
- •Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori)
- •Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form
- •Naïve to H. pylori treatment in the past 6 weeks
排除标准
- •Participation in other interventional trials
- •PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test
- •Pregnant or breastfeeding female
- •Allergy to test substrates
- •Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test
- •Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test.
- •Exposure to any 13C-enriched substance 24 hours prior to the breath test.
- •Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
- •Subjects outside US - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
研究组 & 干预措施
Indication for Helicobacter pylori testing
Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.
干预措施: BreathID® Hp System (Device)
Indication for Helicobacter pylori testing
Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.
干预措施: BreathID® Hp Lab System (Drug)
Indication for Helicobacter pylori testing
Walk in basis: any pediatric subjects with indication for Helicobacter pylori testing will be enrolled if they meet study eligibility criteria and will perform stool test and urea breath test within a week of each other.
干预措施: Stool Test (Diagnostic Test)
结局指标
主要结局
Number of Participants With Reported Adverse Events
时间窗: 24 hours
Number of participants with reported adverse events after performing urea breath test
次要结局
- Percentage of Agreement(1 week)