A Pilot Prospective Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Proportion of the study population identified positive for H. pylori in EST eluates by PCR.
研究概览
简要总结
Background:
Helicobacter pylori is a bacterium that infects the lining of the stomach and intestines. It can cause peptic ulcers, cancers, and infections. Current methods of diagnosing H. pylori infections have limitations. Researchers want to test a new method of testing for H. pylori.
Objective:
To compare the esophageal string test (EST) to standard tests for detecting H. pylori infection.
Eligibility:
People aged 18 years or older with persistent H. pylori infection.
Design:
Participants will have 3 or 4 clinic visits over 2 to 4 months.
Screening visit: Participants will have a physical exam. They will provide a stool sample.
Baseline visit: Participants will have blood tests. Then they will have the EST: One end of a string will be taped to the outside of their cheek; the other end will be packed into a capsule. Participants will swallow the capsule, and the string will unwind down their throat into their stomach. The string will be left in for at least 1 hour. Then researchers will gently pull out the string. The fluids soaked into the string will be studied. Some participants will be prescribed antibiotics.
Follow-up visit 1: Participants whose H. pylori infection was cured by the antibiotics may leave the study. Those who are still infected will have an endoscopy: A flexible tube will be inserted down the throat and into the stomach. It will take tissue samples from the stomach lining. These participants will then receive antibiotics again.
Follow-up visit 2: The physical exam, blood test, and stool sample will be repeated.
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详细描述
Study Description:
Adults with active Helicobacter pylori infection will undergo an esophageal string test (EST). The gastric portion of the string will be used for detection of H. pylori by polymerase chain reaction (PCR), as well as assessment of resistance genes to clarithromycin, levofloxacin, and metronidazole. Participants will be treated per current American Gastroenterological Association (AGA) guidelines. A stool antigen test for H. pylori will be performed 4 weeks after completion of therapy to assess cure. Participants who have failed >=2 courses of therapy will undergo endoscopy with resistance testing per AGA recommendations. Patients will be offered antibiotic therapy based on the EST results and will have a repeat H. pylori stool antigen test 4 weeks after completion of therapy.
Primary Objective:
To assess the sensitivity of the gastric portion of the EST in detecting H. pylori infection.
Secondary Objectives:
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
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Aged >=18 years
- •Diagnosed with H. pylori infection (by endoscopy, stool antigen, or urea breath testing)
- •Agreement to adhere to lifestyle considerations throughout study duration
- •Ability of participant to provide informed consent
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Pregnancy or lactation
- •Use of antibiotics with activity against H. pylori within 4 weeks of enrollment
- •Inability to swallow pills
- •Biopsy-proven high grade dysplastic Barrett s esophagus, active peptic ulcer disease, recent (within 4 weeks) upper GI bleed, and/or history of Zollinger Ellison syndrome or gastric bypass surgery
研究组 & 干预措施
EnteroTracker(R) EST
Esophageal string test device consists of a gelatin-coated capsule with a collection string wrapped inside.
干预措施: EnteroTracker(R) EST (Diagnostic Test)
结局指标
主要结局
Proportion of the study population identified positive for H. pylori in EST eluates by PCR.
时间窗: Baseline
To assess the sensitivity of the gastric portion of the EST in detecting H. pylori infection.
次要结局
- Detection of H. pylori antibiotic resistance genes in EST eluates.(Baseline)