EUCTR2017-001369-25-DE进行中（未招募）1 期
The Sensitivity 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 and GERD Taking Proton Pump Inhibitors
INFAI Institut für biomedizinische Analytik und NMR Imaging GmbH0 个研究点目标入组 226 人开始时间: 2018年2月1日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 226
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 and GERD according Rome IV classification
- •Positive or negative standard 13C-UBT at screening.
- •Diagnosis of H. pylori 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 negative.
- •-Patients will undergo upper endoscopy. Six biopsy samples will be obtained during this procedure.
- •#)Culture will be based on antrum and corpus 2 biopsies.
- •*)two biopsies ( corpus and antrum ) for histology
- •**) two biopsies ( corpus and antrum ) for Rapid urease test(RUT)
- •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 156
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Previous H. pylori eradication therapy.
- •Intake of PPI in 2 weeks, H2 receptor antagonists 1 day and NSAIDs, antibiotics, anti¬secretory 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.
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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 StudyDiagnosis of Helicobacter pylori infection for patients taking proton pump inhibitors (PPI) with one day break of medication instead of two weeks prior to the testEUCTR2008-008010-39-DEINFAI Institut für biomedizinische Analytik und NMR Imaging GmbH86
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