Study of Local Helicobacter Pylori Prevalence and Antibiotic Resistance in Germany with Long-Term Follow-Up and Molecular Analysis

What this Trial Is About

Researchers are investigating the prevalence of Helicobacter pylori infection and antibiotic resistance in Germany, focusing on how socioeconomic factors and age influence infection rates. The study aims to improve detection methods and identify patients at high risk of gastric cancer or precancerous lesions by examining factors such as gastric microbiome signatures. This observational study is designed to gather important data for better risk stratification and treatment decisions. The study is divided into two parts. In Part A, volunteers are screened for H. pylori infection using serologic testing followed by a breath test for confirmation if positive. Participants with confirmed infections who are candidates for endoscopy can enter Part B, where biopsies are collected during clinically indicated gastroscopies to test for antibiotic resistance and to build a biobank for molecular analyses, including microbiome sequencing. Part B also involves long-term observation and detailed laboratory investigations. Participants will undergo initial screening and, if positive, further diagnostic tests including breath tests and endoscopic biopsies when clinically indicated. Researchers will collect and analyze serum, stool, and tissue samples for bacterial subtype, resistance profiles, and microbiome characteristics. The study monitors prevalence and resistance data at 6 months, strain analyses at 1 year, and tracks medical events and cancer risk factors over 10 years. This long-term follow-up provides comprehensive data to support future treatment and prevention strategies.

Helicobacter Pylori Local Prevalence and Antibiotic Resistance