Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Eradication

Treatments: Drug: Clarithromycin; Drug: colloidal bismuth pectin; Drug: Amoxicillin; Drug: esomeprazole; Drug: Minocycline hydrochloride capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04558502

2020-584

Details and patient eligibility

About

Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.

Full description

A total of 339 H. pylori-infected, treatment-naive patients will be enrolled in this randomized controlled clinical trial. Patients will be randomly allocated into 3 groups: Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Eradication rates will be assessed 4-12 weeks after treatment.

Enrollment: 339 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• H.pylori-positive outpatients with endoscopically proven chronic gastritis
• H. pylori (+) determined by either the 14C-or 13C-urea breath test or the gastric mucosal tissue rapid urease test and pathological section staining
• Treatment-naive patients for eradication of H.pylori infection
• Fully informed and agreed to participate in this study

Exclusion criteria

• Age <18 years or >70 years
• Allergy to any of the study drugs
• Use of any drug that could influence the study results 4 weeks before the study,such as antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA)
• Previous gastric or esophageal surgery
• Patients with malignancy or severe comorbidity
• Pregnancy,lactation or alcohol abuse
• Patients with poor treatment compliance or could not express themselves correctly
• Participation in other clinical studies recently (within 3 months of enrollment in this clinical study)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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339 participants in 3 patient groups

minocycline-based bismuth quadruple regimen for 14 days

Experimental group

Description:

Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.

Treatment:

Drug: esomeprazole

Drug: Minocycline hydrochloride capsule

Drug: colloidal bismuth pectin

Drug: Amoxicillin

clarithromycin-based bismuth quadruple regimen for 14 days

Active Comparator group

Description:

Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.

Treatment:

Drug: esomeprazole

Drug: colloidal bismuth pectin

Drug: Amoxicillin

Drug: Clarithromycin

minocycline-based bismuth quadruple regimen for 10 days

Experimental group

Description:

Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.

Treatment:

Drug: esomeprazole

Drug: Minocycline hydrochloride capsule

Drug: colloidal bismuth pectin

Drug: Amoxicillin