Two-way Crossover Comparison of the Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal vs. Standard 13C-Urea Breath Test in Helicobacter Pylori Positive and Negative Patients with Dyspepsia Taking Proton Pump Inhibitors

INFAI GmbH0 个研究点目标入组 115 人开始时间: 2006年8月22日最近更新: 2023年8月21日

试验速览

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•- 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 on samples obtained bz 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 histologz and urease test are negative.
•#) Culture will be based on antrum biopsies
•*) 4 endoscopic biopsies from antrum and 1 biopsy from corpus will be sampled. Histological processing and evaluation will beperformed for at least one sample of the antrum and the corpus.
•**) Rapid urease test will beperformed on the sampke of antrum biopsy.
•- Written informed consent of 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

•Previous Hp eradication therapy
•- intake of PPI, H2 receptors anatgonists, NSAIDs, antibiotics, antisecretory drugs, bismuth compounds, or sucralfate in 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.

发起方

INFAI GmbH