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

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Amoxicillin,Furazolidone; Drug: Amoxicillin,Levofloxacin; Drug: Tetracycline,Furazolidone

• Registration Number: NCT05173493
• 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

• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2021-12-28
• Study Start: 2021-12-30
• Study First Posted: 2021-12-30
• Status Verified: 2023-02
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-10
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

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
Amoxicillin-Furazolidone-containing quadruple group	Amoxicillin,Furazolidone	Patients in amoxicillin-furazolidone-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), amoxicillin1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
Amoxicillin-Levofloxacin-containing quadruple group	Amoxicillin,Levofloxacin	Patients in amoxicillin-Levofloxacin-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), amoxicillin1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.
Tetracycline-Furazolidone-containing quadruple group	Tetracycline,Furazolidone	Patients in tetracycline-furazolidone-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), tetracycline 500 mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

Primary Outcome Measures

Name	Time	Method
The most suitable re-eradication time	6 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	6months	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.

Trial Locations

Locations (1)

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