Pilot Study to Estimate the Prevalence of Helicobacter Pylori (H. Pylori) Infection in Patients Presenting With Non-specific Upper Abdominal Pain to the Emergency Department (ED.)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Prevalence of H. pylori infection in ED patients with symptomatic abdominal pain
研究概览
简要总结
This pilot study aims to estimate the prevalence of Helicobacter pylori (H. pylori) colonization in patients presenting with non-specific abdominal pain (NSAP) in an urban academic emergency department (ED) located in Washington, DC.
详细描述
The major goal is to study the prevalence of H. pylori using the 13C Urea Breath Test (UBT) in emergency department (ED) patients with non-specific abdominal pain. The investigators plan to enroll 250 patients during the pilot stage of this study. This T2 translational trial aims to apply recommended guidelines for the investigation and management of NSAP and dyspepsia into the practical arena of ED clinical care. The "test-and-treat" approach to symptomatic H. pylori infection has been endorsed by the American Gastroenterological Association (AGA). Patients who test positive for H. pylori by UBT will be treated with clarithromycin-based triple medication therapy as recommended by the American College of Gastroenterology (ACG) at the discretion of the treating physician. The rationale is that successful identification of H. pylori in the ED and initiation of treatment may reduce future risk of gastritis, gastric lymphoma, and gastric cancer, and is cost-effective through reduction of future healthcare costs and symptom severity. Study subjects will be followed for medication compliance, resolution of symptoms, and ability to obtain outpatient follow-up. As part of this study, the investigators will be collecting important information on the ED evaluation of abdominal pain.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For any patient with chief complaint of "ABD", "STOM", "EPIG", "CHEST", "NAUS" "Do you have pain or discomfort or burning in your upper abdomen as the main reason for coming to ER today?"
排除标准
- •The patient LESS than 18 years old.
- •Patient does NOT speak English NOR has reliable adult translator.
- •Patient does NOT have capacity to give consent? (confused/intoxicated/etc.)
- •The patient currently is on antibiotics.
- •The patient currently is on a PPI. (eg. Prilosec [omeprazole]), protonix [pantoprazole], prevacid [lansoprazole], aciphex [rabeprazole], nexium [esomeprazole]
- •The patient has taken bismuth or pepto-bismol today.
- •The patient is known to be or suspected to be pregnant.
- •The patient UNABLE to walk to H.pylori Breath test.
- •The patient had "recent" negative H.pylori test for same symptoms.
- •There an "obvious alternative cause" for pain (per attending).
结局指标
主要结局
Prevalence of H. pylori infection in ED patients with symptomatic abdominal pain
时间窗: 6 momths
Prevalence of H. pylori infection diagnosed by UBT in patients with symptomatic upper abdominal pain treated in the ED.
次要结局
- SES measures(6 months)
