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出境医 / 临床实验 / The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province
The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province
Study Description
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.
| Condition or disease |
|---|
| Helicobacter Pylori |
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 |
| Estimated Enrollment : | 1800 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province |
| Actual Study Start Date : | September 1, 2018 |
| Estimated Primary Completion Date : | September 30, 2020 |
| Estimated Study Completion Date : | September 30, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Antimicrobial resistance rate [ Time Frame: 3years ]The antimicrobial resistance rate will be described by the frequency and percentage.
Secondary Outcome Measures :
- 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.
Biospecimen Retention: Samples With DNA
The gastric mucosa of the lesser curvature of gastric antrum and the greater curvature of the stomach
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| 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.
Criteria
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.
Contacts and Locations
Contacts
| Contact: Xiuli Zuo, MD,PhD | 15588818685 ext 053188369277 | zuoxiuli@sina.com | |
| Contact: Tian Ma, MD | 18769781098 ext 053188369277 | matian1002@163.com |
Locations
| China, Shandong | |
| Qilu Hospital of Shandong University | Recruiting |
| Jinan, Shandong, China, 257000 | |
| Contact: Xiuli Zuo, MD,PhD 15588818685 ext 053188369277 zuoxiuli@sina.com | |
| Contact: Tian Ma, MD 18769781098 ext 053188369277 matian1002@163.com | |
| Sub-Investigator: Junnan Hu, MD | |
| Sub-Investigator: Chen Qiao, MD | |
Sponsors and Collaborators
Shandong University
Investigators
| Study Chair: | Xiuli Zuo, MD,PhD | Qilu Hospital of Shandong University | |
| Principal Investigator: | Tian Ma, MD | Qilu Hospital of Shandong University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 21, 2019 | ||||||||
| First Posted Date | July 23, 2019 | ||||||||
| Last Update Posted Date | July 23, 2019 | ||||||||
| Actual Study Start Date | September 1, 2018 | ||||||||
| Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Antimicrobial resistance rate [ Time Frame: 3years ] The antimicrobial resistance rate will be described by the frequency and percentage.
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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.
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province | ||||||||
| Official Title | The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province | ||||||||
| 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 Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
The gastric mucosa of the lesser curvature of gastric antrum and the greater curvature of the stomach
|
||||||||
| 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. | ||||||||
| Condition | Helicobacter Pylori | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1800 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 30, 2020 | ||||||||
| Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
||||||||
| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
|
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04029415 | ||||||||
| Other Study ID Numbers | 2018SDU-QILU-G114 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Xiuli Zuo, Shandong University | ||||||||
| Study Sponsor | Shandong University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
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| PRS Account | Shandong University | ||||||||
| Verification Date | July 2019 | ||||||||