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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04029493
Other study ID # 2018SDU-QILU-G116
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date September 30, 2021

Study information

Verified date July 2019
Source Shandong University
Contact Xiuli Zuo, MD,PhD
Phone 15588818685
Email zuoxiuli@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1800
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
China Qilu Hospital of Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of re-infection The rate of re-infection will be described by the frequency and percentage. 4 years
Secondary The influence factors of the rate of re-infection The chi-square test will be used to compare the influence factors of the rate of re-infection. 4 years
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