EUCTR2008-008010-39-DE进行中（未招募）不适用
The Sensivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal with 13C-Urea Breath Test in Helicobacter Pylori Positive and Negative Patients with Dyspepsia Taking Proton Pump Inhibitors - PPI Study
INFAI Institut für biomedizinische Analytik und NMR Imaging GmbH0 个研究点目标入组 86 人开始时间: 2009年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Male and female patients of at least 18 years of age
- •·All acid-related disorders requiring long-term PPI treatment including functional
- •dyspepsia according Rome II classification.
- •·Positive or negative standard 13C-UBT at screening.
- •·Diagnosis of Hp infection confirmed or excluded by combination of culture#,
- •histology* and rapid** urease test (PyloriTek®, Serim Research Corp., Elkhart,
- •USA) on samples obtained by endoscopy:
- •-True positive: culture and/or (histology and rapid urease test) are positive
- •-True negative: at least two tests are negative and culture is not positive
- •-True negative: culture not evaluable and both histology and urease test are
- •Culture will be based on antrum biopsies.
- •4 endoscopic biopsies from the antrum and 1 biopsy from the corpus, and 1
- •biopsy from the angular fold will be sampled. Histological processing and
- •evaluation will be performed for at least one sample of the antrum and the
- •Rapid urease test will be performed on the sample of angular fold biopsy.
- •·Written informed consent of the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Previous Hp eradication therapy.
- •·Intake of PPI, H2 receptor antagonists, NSAIDs, antibiotics, antisecretory drugs,
- •bismuth compounds, or sucralfate in the 4 weeks prior to enrolment.
- •·Manifest coagulopathy or any other disorder according to which endoscopy and/or
- •biopsies are contraindicated.
- •·Participation in a clinical trial with another not approved drug within 30 days before
- •entering the study and/or previous participation in this study.
研究者
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