Clinical trial NCT04558502: Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
Official title: Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy as First-Line Regimen for Helicobacter Pylori Eradication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Eradication
Keywords: Helicobacter pylori
Eradication
minocycline
bismuth quadruple regimens
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Eradication rate
timeFrame: 4-12 weeks after treatment
Secondary outcomes:
measure: incidence of adverse effects
timeFrame: 3-7 days after treatment
Other outcomes:
Locations:
Study officials:
affiliation: 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
name: Qin Du, master
role: PRINCIPAL_INVESTIGATOR
References: