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

December 26, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

339

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Minocycline hydrochloride capsule
Antibiotic for H. pylori eradication
Other Names:
  • Meiman
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: Amoxicillin
Antibiotic for H. pylori eradication
Drug: colloidal bismuth pectin
Gastric mucosal protective drug with anti-H. pylori effect
Drug: esomeprazole
Proton pump inhibitor
Drug: Clarithromycin
Antibiotic for H. pylori eradication
Other Names:
  • Klacid
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: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Minocycline hydrochloride capsule
Antibiotic for H. pylori eradication
Other Names:
  • Meiman
Drug: colloidal bismuth pectin
Gastric mucosal protective drug with anti-H. pylori effect
Drug: esomeprazole
Proton pump inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate
Time Frame: 4-12 weeks after treatment
Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy
4-12 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of adverse effects
Time Frame: 3-7 days after treatment
incidence of adverse effects of minocycline-containing bismuth quadruple therapy
3-7 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Qin Du, master, 2nd affiliated Hospital,School of Medicine,Zhejiang University,China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 5, 2022

Primary Completion (Anticipated)

June 5, 2022

Study Completion (Anticipated)

December 5, 2022

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 20, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 26, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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