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NCT04029415 Clinical Trial

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

Helicobacter Pylori Clinical Trial

Official title:
The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04029415
Other study ID # 2018SDU-QILU-G114
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date September 30, 2020

Study information
Verified date July 2019
Source Shandong University
Contact Xiuli Zuo, MD,PhD
Phone 15588818685
Email zuoxiuli@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1800
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Qilu Hospital of Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Antimicrobial resistance rate The antimicrobial resistance rate will be described by the frequency and percentage. 3years
Secondary The influence factors of the antimicrobial resistance rate The chi-square test will be used to compare the influence factors of the antimicrobial resistance rate. 3years
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