Primary Antimicrobial Resistance Patterns of Austrian Helicobacter Pylori Clinical Isolates

Helicobacter pylori infects ~ 50% of the world's population and a quarter of the European population. H. pylori is responsible for a large proportion of gastric and duodenal ulcers and gastritis. Chronic infection with H. pylori is a risk factor for the development of stomach cancer and MALT (mucosa-associated lymphoid tissue) Lymphoma. The prospects of success for an antimicrobial eradication therapy is drastically reduced by the significant increase in antibiotic resistance in Austrian H. pylori isolates. The currently available data were obtained however from narrowly defined geographical regions and the clinical routine without information on patient selection. We suspect a considerable geographical variability of resistance patterns and a clinical bias for a preferential investigation of patients with unsuccessful, empirical eradication therapy. The objective of the proposed study is therefore an Austria-wide collection of data on H. pylori resistance in a prospective clinical study. The data thus collected will enable a significant improvement in current treatment recommendations.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection

• Study Type: Observational
• Enrollment (Actual): 2000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Undergoing a diagnostic gastroscopy for the first time in their lives or had a diagnostic gastroscopy for any reason >10 years ago

Description

Inclusion Criteria:

• Undergoing a diagnostic gastroscopy for the first time in their lives or had a diagnostic gastroscopy for any reason >10 years ago
• Older than 18 years of age
• Written informed consent

Exclusion Criteria:

• Previous H. pylori eradication therapies
• Antimicrobial treatment for other reasons than H. pylori eradication within 3 months prior to gastroscopy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antimicrobial resistance of H. pylori isolate	1 day (Once)

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Publications and helpful links

General Publications

• Bilgilier C, Stadlmann A, Makristathis A, Thannesberger J, Kastner MT, Knoflach P, Steiner P, Schoniger-Hekele M, Hogenauer C, Blesl A, Datz C, Huber-Schonauer U, Schofl R, Wewalka F, Puspok A, Mitrovits N, Leiner J, Tilg H, Effenberger M, Moser M, Siebert F, Hinterberger I, Wurzer H, Stupnicki T, Watzinger N, Gombotz G, Hubmann R, Klimpel S, Biowski-Frotz S, Schrutka-Kolbl C, Graziadei I, Ludwiczek O, Kundi M, Hirschl AM, Steininger C; Austrian Helicobacter Study Group of the Austrian Society of Gastroenterology and Hepatology. Prospective multicentre clinical study on inter- and intrapatient genetic variability for antimicrobial resistance of Helicobacter pylori. Clin Microbiol Infect. 2018 Mar;24(3):267-272. doi: 10.1016/j.cmi.2017.06.025. Epub 2017 Jun 29.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MUVienna_Helicobacter