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NCT05493644 Clinical Trial

A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

Helicobacter Pylori Infection Clinical Trial

Official title:
A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05493644
Other study ID # 2022-SDU-QILU-G808
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date December 31, 2023

Study information
Verified date August 2022
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Description:

Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment inpatients with Hp eradication failure.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 660
Est. completion date December 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients aged 18-70 with H. pylori infection. - Patients with previous Helicobacter pylori eradication. Exclusion Criteria: - Patients treated with H2-receptor antagonist, PPI, bismuth and antibioticsin the previous 4 weeks. - Patients with gastrectomy, acute GI bleeding and advanced gastric cancer. - Patients with known or suspected allergy to study medications. - Currently pregnant or lactating. - Inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Remedial treatment within 3 months
Remedial therapy was performed within 3 months
• Remedial treatment within 3 to 6 months
Remedial therapy was performed within 3 to 6 months
• Remedial treatment within 6 to 12 months
Remedial therapy was performed within 6 to 12 months
• Remedial treatment after 12 months
Remedial therapy was performed after 12 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Outcome
Type Measure Description Time frame Safety issue
Primary The most suitable re-eradication time The most suitable re-eradication time#The unit is month# will be assessed by paired comparison method . 12 months
Secondary Eradication rates in three groups Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in three groups 12 months
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