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

Completed

• Conditions: Helicobacter Pylori
• Interventions: Drug: Amoxicillin , Levofloxacin and Esomeprazole; Drug: Tetracycline , Furazolidone and Esomeprazole; Drug: Amoxicillin,Furazolidone and Vonoprazan fumarate; Drug: Tetracycline,Furazolidone and Vonoprazan fumarate; Drug: Amoxicillin , Furazolidone and Esomeprazole; Drug: Amoxicillin,Levofloxacin and Vonoprazan fumarate

• Registration Number: NCT04810793
• 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 in patients with Hp eradication failure.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-21
• Study First Posted: 2021-03-23
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

• Patients, aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group	Amoxicillin , Levofloxacin and Esomeprazole	Patients in amoxicillin-levofloxacin-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.
Tetracycline-Furazolidone-Esomeprazole-containing quadruple group	Tetracycline , Furazolidone and Esomeprazole	Patients in tetracycline-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group	Amoxicillin,Furazolidone and Vonoprazan fumarate	Patients in amoxicillin-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group	Tetracycline,Furazolidone and Vonoprazan fumarate	Patients in tetracycline-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group	Amoxicillin , Furazolidone and Esomeprazole	Patients in amoxicillin-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.
Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group	Amoxicillin,Levofloxacin and Vonoprazan fumarate	Patients in amoxicillin-levofloxacin-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.

Primary Outcome Measures

Name	Time	Method
The most suitable re-eradication time	1year	The most suitable re-eradication time will be assessed by paired comparison method .

Trial Locations

Locations (1)

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