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Clinical Trials/NCT04029415
NCT04029415UnknownNot Applicable

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

Shandong University1 site in 1 country1,800 target enrollmentStarted: September 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,800
Locations
1
Primary Endpoint
Antimicrobial resistance rate

Study Overview

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Antimicrobial resistance rate

Time Frame: 3years

The antimicrobial resistance rate will be described by the frequency and percentage.

Secondary Outcomes

  • The influence factors of the antimicrobial resistance rate(3years)

Investigators

Sponsor
Shandong University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiuli Zuo

director of Qilu Hospital gastroenterology department

Shandong University

Study Sites (1)

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