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

NCT ID: NCT04558502

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2022-12-05

Brief Summary

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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

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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.

Conditions

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Helicobacter Pylori Eradication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Minocycline hydrochloride capsule

Intervention Type DRUG

Antibiotic for H. pylori eradication

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

colloidal bismuth pectin

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

esomeprazole

Intervention Type DRUG

Proton pump inhibitor

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.

Group Type ACTIVE_COMPARATOR

Clarithromycin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

colloidal bismuth pectin

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

esomeprazole

Intervention Type DRUG

Proton pump inhibitor

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.

Group Type EXPERIMENTAL

Minocycline hydrochloride capsule

Intervention Type DRUG

Antibiotic for H. pylori eradication

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

colloidal bismuth pectin

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

esomeprazole

Intervention Type DRUG

Proton pump inhibitor

Interventions

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Minocycline hydrochloride capsule

Antibiotic for H. pylori eradication

Intervention Type DRUG

Clarithromycin

Antibiotic for H. pylori eradication

Intervention Type DRUG

Amoxicillin

Antibiotic for H. pylori eradication

Intervention Type DRUG

colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Intervention Type DRUG

esomeprazole

Proton pump inhibitor

Intervention Type DRUG

Other Intervention Names

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Meiman Klacid

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qin Du, master

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital,School of Medicine,Zhejiang University,China

Central Contacts

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Yan Li, master

Role: CONTACT

15906698496

Yuehua Han, PhD

Role: CONTACT

13858126927

Other Identifiers

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2020-584

Identifier Type: -

Identifier Source: org_study_id

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