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

July 21, 2019 updated by: Xiuli Zuo, Shandong University
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 257000
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Sub-Investigator:
          • Junnan Hu, MD
        • Sub-Investigator:
          • Chen Qiao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients in Shandong province, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antimicrobial resistance rate
Time Frame: 3years
The antimicrobial resistance rate will be described by the frequency and percentage.
3years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The influence factors of the antimicrobial resistance rate
Time Frame: 3years
The chi-square test will be used to compare the influence factors of the antimicrobial resistance rate.
3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Study Chair: Xiuli Zuo, MD,PhD, Qilu Hospital of Shandong University
  • Principal Investigator: Tian Ma, MD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

July 21, 2019

First Submitted That Met QC Criteria

July 21, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 21, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018SDU-QILU-G114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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