The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province
1 other identifier
observational
1,800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 21, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedJuly 23, 2019
July 1, 2019
2.1 years
July 21, 2019
July 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antimicrobial resistance rate
The antimicrobial resistance rate will be described by the frequency and percentage.
3years
Secondary Outcomes (1)
The influence factors of the antimicrobial resistance rate
3years
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu Hospital of Shandong University
Jinan, Shandong, 257000, China
Biospecimen
The gastric mucosa of the lesser curvature of gastric antrum and the greater curvature of the stomach
Study Officials
- STUDY CHAIR
Xiuli Zuo, MD,PhD
Qilu Hospital of Shandong University
- PRINCIPAL INVESTIGATOR
Tian Ma, MD
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of Qilu Hospital gastroenterology department
Study Record Dates
First Submitted
July 21, 2019
First Posted
July 23, 2019
Study Start
September 1, 2018
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
July 23, 2019
Record last verified: 2019-07