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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04558502

Collaborator

(none)

339

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Eradication	Drug: Minocycline hydrochloride capsule Drug: Clarithromycin Drug: Amoxicillin Drug: colloidal bismuth pectin Drug: esomeprazole	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

339 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy as First-Line Regimen for Helicobacter Pylori Eradication

Anticipated Study Start Date :

Jan 5, 2022

Anticipated Primary Completion Date :

Jun 5, 2022

Anticipated Study Completion Date :

Dec 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: minocycline-based bismuth quadruple regimen for 14 days Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.	Drug: Minocycline hydrochloride capsule Antibiotic for H. pylori eradication Other Names: Meiman Drug: Amoxicillin Antibiotic for H. pylori eradication Drug: colloidal bismuth pectin Gastric mucosal protective drug with anti-H. pylori effect Drug: esomeprazole Proton pump inhibitor
Active Comparator: clarithromycin-based bismuth quadruple regimen for 14 days Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.	Drug: Clarithromycin Antibiotic for H. pylori eradication Other Names: Klacid Drug: Amoxicillin Antibiotic for H. pylori eradication Drug: colloidal bismuth pectin Gastric mucosal protective drug with anti-H. pylori effect Drug: esomeprazole Proton pump inhibitor
Experimental: minocycline-based bismuth quadruple regimen for 10 days Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.	Drug: Minocycline hydrochloride capsule Antibiotic for H. pylori eradication Other Names: Meiman Drug: Amoxicillin Antibiotic for H. pylori eradication Drug: colloidal bismuth pectin Gastric mucosal protective drug with anti-H. pylori effect Drug: esomeprazole Proton pump inhibitor

Arm

Intervention/Treatment

Experimental: minocycline-based bismuth quadruple regimen for 14 days

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

Drug: Minocycline hydrochloride capsule

Antibiotic for H. pylori eradication

Other Names:

Meiman

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Drug: colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Drug: esomeprazole

Proton pump inhibitor

Active Comparator: clarithromycin-based bismuth quadruple regimen for 14 days

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

Drug: Clarithromycin

Antibiotic for H. pylori eradication

Other Names:

Klacid

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Drug: colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Drug: esomeprazole

Proton pump inhibitor

Experimental: minocycline-based bismuth quadruple regimen for 10 days

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

Drug: Minocycline hydrochloride capsule

Antibiotic for H. pylori eradication

Other Names:

Meiman

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Drug: colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Drug: esomeprazole

Proton pump inhibitor

Outcome Measures

Primary Outcome Measures

Eradication rate [4-12 weeks after treatment]
Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy

Secondary Outcome Measures

incidence of adverse effects [3-7 days after treatment]
incidence of adverse effects of minocycline-containing bismuth quadruple therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

H.pylori-positive outpatients with endoscopically proven chronic gastritis
1. 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)