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

Shandong University

Status: Completed

Conditions: Helicobacter Pylori

Treatments: Drug: Amoxicillin , Levofloxacin and Esomeprazole; Drug: Tetracycline,Furazolidone and Vonoprazan fumarate; Drug: Tetracycline , Furazolidone and Esomeprazole; Drug: Amoxicillin,Furazolidone and Vonoprazan fumarate; Drug: Amoxicillin,Levofloxacin and Vonoprazan fumarate; Drug: Amoxicillin , Furazolidone and Esomeprazole

Study type: Observational

Funder types: Other

Identifiers

NCT04810793

2020-SDU-QILU-G101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 820 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

820 participants in 6 patient groups

Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group

Description:

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.

Treatment:

Drug: Amoxicillin , Levofloxacin and Esomeprazole

Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group

Description:

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.

Treatment:

Drug: Amoxicillin , Furazolidone and Esomeprazole

Tetracycline-Furazolidone-Esomeprazole-containing quadruple group

Description:

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.

Treatment:

Drug: Tetracycline , Furazolidone and Esomeprazole

Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group

Description:

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.

Treatment:

Drug: Amoxicillin,Levofloxacin and Vonoprazan fumarate

Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group

Description:

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.

Treatment:

Drug: Amoxicillin,Furazolidone and Vonoprazan fumarate

Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

Description:

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.

Treatment:

Drug: Tetracycline,Furazolidone and Vonoprazan fumarate