Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen tests, histology or the Helicobacter urease test (HUT). The aim of our study is to access the clinical reliability of a new, electrochemical device for rapid H. pylori detection.
The newly developed electrochemical device for H. pylori detection consists of a working and reference electrode between which a biopsy sample is administered. Afterwards, acquired voltage-values could be analysed for characteristics typical for H. pylori infection (ammonia). According to Sydney classification, biopsies are taken from gastric antrum and corpus for electrochemical H. pylori detection, HUT and immunohistochemistry (IHC). HUT results are evaluated after 24 hours. Furthermore, every patient will receive 13C-urea breath test. IHC is designated as the gold standard of H. pylori diagnosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Determination of H. pylori infection.
Determination of H. pylori infection.
Determination of H. pylori infection.
University of Erlangen-Nuremberg
Erlangen, Bavaria, Germany
Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.
Time frame: Oktober 2009 - February 2011
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Determination of H. pylori infection.