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

Helicobacter Pylori Eradication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04558502
• Other study ID #: 2020-584
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 5, 2022
• Est. completion date: December 5, 2022

Study information

• Verified date: December 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yan Li, master
• Phone: 15906698496
• Email: liyan_8786[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 339
• Est. completion date: December 5, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate	Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy	4-12 weeks after treatment
Secondary	incidence of adverse effects	incidence of adverse effects of minocycline-containing bismuth quadruple therapy	3-7 days after treatment