The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province

• Conditions: Helicobacter Pylori

• Registration Number: NCT04029415
• Lead Sponsor: Shandong University

Brief Summary

The antimicrobial resistance of helicobacter pylori in Shandong province was analyzed by helicobacter pylori antibiotic sensitivity test.And the map of antimicrobial resistance of helicobacter pylori was constructed to provide clinical guidance for selecting effective eradication program and improve the eradication rate.

Detailed Description

The patients with positive H. pylori infection that was not eradicated by previous therapies will accept the gastroscopy. The mucosa of the lesser curvature of gastric antrum and the greater curvature of the stomach will progress helicobacter pylori antibiotic sensitivity test to detect the antimicrobial resistance of helicobacter pylori.The antimicrobial resistance of helicobacter pylori in Shandong province will be described by frequency and percentage.

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-21
• Study First Submitted QC: 2019-07-21
• Last Update Submitted: 2019-07-21
• Study First Posted: 2019-07-23
• Last Update Posted: 2019-07-23
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

• Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria

• Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antimicrobial resistance rate	3years	The antimicrobial resistance rate will be described by the frequency and percentage.

Secondary Outcome Measures

Name	Time	Method
The influence factors of the antimicrobial resistance rate	3years	The chi-square test will be used to compare the influence factors of the antimicrobial resistance rate.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China