HelicoPTER study: Improving the clinical management of H. pylori infections
Almost every second person worldwide is infected with the pathogenic bacterium Helicobacter pylori that causes chronic gastritis. In about 15 percent of infected individuals, gastric inflammation leads to peptic ulcers, and in one to two percent even to stomach cancer. Timely detection and treatment of the infection with antibiotics has been shown to reduce the risk of developing stomach cancer. However, therapeutic success is increasingly hampered by antibiotic resistance of the bacteria. The HelicoPTER (short for: Helicobacter pylori prevalence and antibiotic resistance situation) clinical study aims to improve the data basis for clinical management of infections with the gastric pathogen—in diagnostics as well as treatment.
The clinical management of H. pylori infections depends mainly on two factors: the prevalence and the local resistance situation. Currently, only limited data from rather small and outdated cohorts exist on both parameters in Germany. Knowledge of the current regional prevalence (including socioeconomic factors and age) as well as on antibiotic resistance is indispensable for the selection of appropriate detection methods and efficient therapies.
The initial aim of the HelicoPTER study is to collect data on the frequency and severity of H. pylori infections and on the antibiotic resistance situation in Germany in a cross-sectional study. Knowledge of the resistance situation is necessary for the selection of suitable empiric treatment protocols. In addition, molecular detection methods will be compared with conventional microbiological methods in order to diagnose resistance more quickly.
Furthermore, long-term monitoring of study participants who tested positive for H. pylori will be carried out. The aim is to identify specific parameters which enable the early detection of H. pylori infected individuals who are at high risk of progressing to gastric cancer or already have precancerous lesions as a result of the infection. In this way, factors relevant to carcinogenesis are tobe identified, which, in the sense of risk stratification, can determine patients who are most likely to benefit from targeted H. pylori diagnostics and endoscopy.
The centres involved in the study at the Hannover Medical School, the University Hospital Tübingen, as well as the Ludwig-Maximilians-Universität München and the Technical University of Munich are therefore looking for study participants (https://helicobacter-testen.de/). Probands can be tested for H. pylori free of charge by means of a blood test and – in case of a positive serology – a 13C urea breath test. If an infection is confirmed, gastroscopy is offered to assess the gastric mucosa and isolate the pathogen with resistance testing. Treatment can then be tailored to the resistance profile.
More information about the study and a link to register as a study participant (in German) can be found here: helicobacter-testen.de.
