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

• Conditions: Helicobacter Pylori Infection
• Interventions: Other: Remedial treatment within 3 to 6 months; Other: Remedial treatment within 3 months; Other: Remedial treatment within 6 to 12 months; Other: Remedial treatment after 12 months

• Registration Number: NCT05493644
• Lead Sponsor: Shandong University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Study Start: 2022-09-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 660

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group B	Remedial treatment within 3 to 6 months	Within 3 to 6 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d.
group A	Remedial treatment within 3 months	Within 3 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d.
group C	Remedial treatment within 6 to 12 months	Within 6 to 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d.
group D	Remedial treatment after 12 months	After 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d.

Primary Outcome Measures

Name	Time	Method
The most suitable re-eradication time	12 months	The most suitable re-eradication time#The unit is month# will be assessed by paired comparison method .

Secondary Outcome Measures

Name	Time	Method
Eradication rates in three groups	12 months	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