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

Shandong University

Status: Not yet enrolling

Conditions: Helicobacter Pylori Infection

Treatments: Other: Remedial treatment within 6 to 12 months; Other: Remedial treatment within 3 to 6 months; Other: Remedial treatment within 3 months; Other: Remedial treatment after 12 months

Study type: Observational

Funder types: Other

Identifiers

NCT05493644

2022-SDU-QILU-G808

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 inpatients with Hp eradication failure.

Enrollment: 660 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

660 participants in 4 patient groups

group A

Description:

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.

Treatment:

Other: Remedial treatment within 3 months

group B

Description:

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.

Treatment:

Other: Remedial treatment within 3 to 6 months

group C

Description:

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.

Treatment:

Other: Remedial treatment within 6 to 12 months

group D

Description:

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.

Treatment:

Other: Remedial treatment after 12 months