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

Sponsor

Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04810793

Collaborator

Taian City Central Hospital (Other), Dezhou People's Hospital (Other), Weifang Medical University (Other), The Affiliated Hospital of Qingdao University (Other), Shengli Oilfield Hospital (Other)

1,000

Enrollment

Location

Anticipated Duration (Months)

41.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Drug: Amoxicillin , Levofloxacin and Esomeprazole Drug: Amoxicillin , Furazolidone and Esomeprazole Drug: Tetracycline , Furazolidone and Esomeprazole Drug: Amoxicillin,Levofloxacin and Vonoprazan fumarate Drug: Amoxicillin,Furazolidone and Vonoprazan fumarate Drug: Tetracycline,Furazolidone and Vonoprazan fumarate

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group 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.	Drug: Amoxicillin , Levofloxacin and Esomeprazole Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens
Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group 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.	Drug: Amoxicillin , Furazolidone and Esomeprazole Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens
Tetracycline-Furazolidone-Esomeprazole-containing quadruple group 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.	Drug: Tetracycline , Furazolidone and Esomeprazole Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens
Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group 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.	Drug: Amoxicillin,Levofloxacin and Vonoprazan fumarate Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group
Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group 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.	Drug: Amoxicillin,Furazolidone and Vonoprazan fumarate Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group
Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group 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.	Drug: Tetracycline,Furazolidone and Vonoprazan fumarate Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

Outcome Measures

Primary Outcome Measures

The most suitable re-eradication time [1year]
The most suitable re-eradication time will be assessed by paired comparison method .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.