PPI-amoxicillin for H. Pylori Treatment

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Rabeprazole; Drug: Metronidazole; Drug: Bismuth potassium citrate; Drug: Amoxicillin

• Registration Number: NCT05014685
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

This randomized controlled clinical trial will identify the additional benefit of bismuth or metronidazole in proton pump inhibitor-amoxicillin-containing therapy for Helicobacter pylori first-line treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-14
• Study Start: 2021-08-20
• Study First Posted: 2021-08-20
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 732

Inclusion Criteria

• Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
• 18-75 years old on the day of signing the ICF.
• Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
• Have not received Helicobacter pylori eradication treatment before.

Exclusion Criteria

• Have received Hp eradication treatment.
• Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
• Subjects or guardians refused to participate in the trial.
• Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
• Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
• Pregnant or lactating women.
• Active peptic ulcer.
• allergic to drugs used in the trial.
• any other circumstances that are not suitable for recruitment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
RAB group	Rabeprazole	-
RAM group	Metronidazole	-
RAM group	Amoxicillin	-
RAB group	Bismuth potassium citrate	-
RABM group	Bismuth potassium citrate	-
RAM group	Rabeprazole	-
RA group	Rabeprazole	-
RA group	Amoxicillin	-
RAB group	Amoxicillin	-
RABM group	Rabeprazole	-
RABM group	Metronidazole	-
RABM group	Amoxicillin	-

Primary Outcome Measures

Name	Time	Method
Eradication rate of Helicobacter pylori	At least 4 weeks after completion of therapy	Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).

Secondary Outcome Measures

Name	Time	Method
Eradication rate of Helicobacter pylori resistant strains	At least 4 weeks after completion of therapy	Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.
Eradication rate of Helicobacter pylori susceptible strains	At least 4 weeks after completion of therapy	Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China