The Situation of Re-infection of Helicobacter Pylori After Successful Eradication
Sponsor
Shandong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04029493
Collaborator
(none)
1,800
1
37
48.7
Study Details
Study Description
Brief Summary
The patients who accept the quadruple eradication program of the helicobacter pylori and success to eradicate helicobacter pylori will be followed-up to observe the situation of re-infection of helicobacter pylori.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
The patients with helicobacter pylori accepted he quadruple eradication program of the helicobacter pylori.They will be followed-up from 1 year to 5 years to observe the situation of re-infection of helicobacter pylori.The rate of the re-infection 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 Situation of Re-infection of Helicobacter Pylori After Successful Eradication
Actual Study Start Date
:
Sep 1, 2018
Anticipated Primary Completion Date
:
Sep 30, 2021
Anticipated Study Completion Date
:
Sep 30, 2021
Outcome Measures
Primary Outcome Measures
- The rate of re-infection [4 years]
The rate of re-infection will be described by the frequency and percentage.
Secondary Outcome Measures
- The influence factors of the rate of re-infection [4 years]
The chi-square test will be used to compare the influence factors of the rate of re-infection.
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:
NCT04029493
Other Study ID Numbers:
- 2018SDU-QILU-G116
First Posted:
Jul 23, 2019
Last Update Posted:
Jul 23, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms: