Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Summary

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Conditions

• Helicobacter Pylori Infection

Interventions

DRUG

Amoxicillin

Use according to the drug combination options selected by each center.

DRUG

Clarithromycin

Use according to the drug combination options selected by each center.

DRUG

Tetracycline

Use according to the drug combination options selected by each center.

DRUG

Metronidazole

Use according to the drug combination options selected by each center.

DRUG

Bismuth Potassium Citrate

Use according to the drug combination options selected by each center.

DRUG

Colloidal Bismuth Pectin

Use according to the drug combination options selected by each center.

DRUG

Vonoprazan fumarate

Use according to the drug combination options selected by each center.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• The People's Hospital of Guangrao

  collaborator UNKNOWN

• Weihai Municipal Hospital

  collaborator OTHER

• Shandong Province Third hospital

  collaborator OTHER

• Taian City Central Hospital

  collaborator OTHER

• Jining No.2 People's Hospital

  collaborator UNKNOWN

• Maternity and Child Care Health Center of Dezhou

  collaborator UNKNOWN

• Zoucheng People's Hospital

  collaborator UNKNOWN

• Heze Municipal 3rd people's hospital

  collaborator UNKNOWN

• Yuncheng Chengxin Hospital

  collaborator UNKNOWN

• Peking University Care Luzhong Hospital

  collaborator OTHER

• Qihe County City Hospital

  collaborator UNKNOWN

• Weifang People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Shandong Electric Power Central Hospital

  collaborator UNKNOWN

• Shandong University

  lead OTHER

Principal Investigators

• Xiuli Zuo, MD,PhD · Qilu Hospital of Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-30

Primary Completion

2023-06-30

Completion

2023-08-31

Countries

• China

Study Locations