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

• Sponsor: Shandong University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04029415
• Collaborator: (none)
• Enrollment: 1,800
• Location: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 72.1

Study Details

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	Intervention/Treatment	Phase
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
• Anticipated 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: Sep 1, 2018
• Anticipated Primary Completion Date: Sep 30, 2020
• Anticipated Study Completion Date: Sep 30, 2020

Outcome Measures

Primary Outcome Measures

1. Antimicrobial resistance rate [3years]

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

Secondary Outcome Measures

1. The influence factors of the antimicrobial resistance rate [3years]

   The chi-square test will be used to compare the influence factors of the antimicrobial resistance rate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Qilu Hospital of Shandong University	Jinan	Shandong	China	257000

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
• ClinicalTrials.gov Identifier: NCT04029415
• Other Study ID Numbers: 2018SDU-QILU-G114
• First Posted: Jul 23, 2019
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University: antimicrobial resistance

Study Results

No Results Posted as of Jul 23, 2019