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NCT05173493 Clinical Trial

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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05173493
Other study ID # 2021-SDU-QILU-G101
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 30, 2021
Est. completion date February 10, 2023

Study information
Verified date February 2023
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 Completed
Enrollment 670
Est. completion date February 10, 2023
Est. primary completion date February 10, 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

Drug:
• Amoxicillin,Furazolidone
Amoxicillin-Furazolidone-containing quadruple group
• Amoxicillin,Levofloxacin
Amoxicillin-Levofloxacin-containing quadruple group
• Tetracycline,Furazolidone
Tetracycline-Furazolidone-containing quadruple group

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

Sponsors (6)
Lead Sponsor Collaborator
Shandong University Dezhou People's Hospital, Shengli Oilfield Hospital, Taian City Central Hospital, The Affiliated Hospital of Qingdao University, Weifang Medical University

Country where clinical trial is conducted

China, 

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 . 6 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. 6months
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