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

Phase 4

• Conditions: Helicobacter Pylori Eradication
• Interventions: Drug: Minocycline hydrochloride capsule; Drug: Clarithromycin; Drug: Amoxicillin; Drug: colloidal bismuth pectin; Drug: esomeprazole

• Registration Number: NCT04558502
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-20
• Study First Posted: 2020-09-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-26
• Study Start: 2022-01-05
• Last Update Posted: 2022-01-13
• Primary Completion: 2022-06-05
• Study Completion: 2022-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 339

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
minocycline-based bismuth quadruple regimen for 14 days	Minocycline hydrochloride capsule	Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
minocycline-based bismuth quadruple regimen for 14 days	colloidal bismuth pectin	Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
clarithromycin-based bismuth quadruple regimen for 14 days	colloidal bismuth pectin	Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
minocycline-based bismuth quadruple regimen for 10 days	Minocycline hydrochloride capsule	Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.
minocycline-based bismuth quadruple regimen for 10 days	colloidal bismuth pectin	Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.
minocycline-based bismuth quadruple regimen for 14 days	Amoxicillin	Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
minocycline-based bismuth quadruple regimen for 14 days	esomeprazole	Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
clarithromycin-based bismuth quadruple regimen for 14 days	Amoxicillin	Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
clarithromycin-based bismuth quadruple regimen for 14 days	Clarithromycin	Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
clarithromycin-based bismuth quadruple regimen for 14 days	esomeprazole	Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
minocycline-based bismuth quadruple regimen for 10 days	Amoxicillin	Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.
minocycline-based bismuth quadruple regimen for 10 days	esomeprazole	Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.

Primary Outcome Measures

Name	Time	Method
Eradication rate	4-12 weeks after treatment	Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy

Secondary Outcome Measures

Name	Time	Method
incidence of adverse effects	3-7 days after treatment	incidence of adverse effects of minocycline-containing bismuth quadruple therapy