Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community-AIM 2
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Standard vs At-Home Retesting for eradication
研究概览
简要总结
H. pylori is an infection of the stomach that can cause chronic gastritis, gastric cancer and peptic ulcer disease. The goal of this study is to screen people for this infection and offer treatment for those who test positive for the infection. By treating those who are positive for H. pylori, there is an opportunity to prevent gastritis, peptic ulcer disease, and even gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in Aim 1 that received a positive result for H. Pylori (HP) testing
- •Participants are advised to only begin re-testing procedures in Aim 2 if they have finished the medication regimen for HP treatment at least 6 weeks ago
排除标准
- •Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed
研究组 & 干预措施
At-Home Retesting Strategy
Participants who test positive for H. pylori (HP), will receive a kit that contains a PYtest® 14C-Urea Breath Test (TriMed). Participants will complete the retest at-home at least 6 weeks after treatment. Study team will contact the participant to inquire about retesting and the post treatment survey. The kit will include an envelope, materials for the test, and a return form. PYtest® is a quantitative and non-invasive method for the diagnosis of HP. The test is conducted with the swallowing of a urea capsule. If gastric urease from HP is present, the urea is split to form carbon dioxide and ammonia. Ten minutes after the capsule is ingested, a breath sample is collected in a balloon. The balloon is tied and mailed along with the return form to be analyzed by an outside laboratory. The study team will call the participant to provide results. Those who retest positive will be instructed to seek treatment from their primary care provider.
干预措施: PYTEST® 14C-Urea Capsule Breath Test (at Home) (Drug)
Standard Care Retesting Strategy
Participants who test positive for H. pylori (HP), will complete their retest in-person with the study team. Study team will contact the participant to inquire about scheduling the retest and the post treatment survey. Retest will be completed in Don Soffer or at one of study's community sites. PYtest® is a urea breath test and is a quantitative and non-invasive method for the diagnosis of HP. The test is conducted with the participant swallowing a urea capsule. If gastric urease from HP is present, the urea is split to form carbon dioxide and ammonia. Ten minutes after the capsule is ingested by the participant, a breath sample is collected in a balloon. This liquid is analyzed on site by the liquid scintillation counter, by the study team. Those who test positive will be instructed to seek treatment for H. pylori infection.
干预措施: PYTEST® 14C-Urea Capsule Breath Test (Standard Retesting In-Person) (Drug)
结局指标
主要结局
Standard vs At-Home Retesting for eradication
时间窗: 6 weeks after completion of treatment
Percent of participants who complete at-home retesting, compared to the percent of participants who complete standard retesting, with successful eradication defined as obtaining a negative test result upon retesting.
次要结局
未报告次要终点
研究者
Shria Kumar
Assistant Professor of Clinical Medicine
University of Miami