The Situation of Re-infection of Helicobacter Pylori After Successful Eradication

• Conditions: Helicobacter Pylori

• Registration Number: NCT04029493
• Lead Sponsor: Shandong University

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.

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 Timeline

• Study Start: 2018-09-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-21
• Study First Submitted QC: 2019-07-21
• Last Update Submitted: 2019-07-21
• Study First Posted: 2019-07-23
• Last Update Posted: 2019-07-23
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of re-infection	4 years	The rate of re-infection will be described by the frequency and percentage.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China