Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection
Efficacy of Quadruple Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests as First-line Treatment for Helicobacter Pylori Infection
1 other identifier
interventional
855
1 country
1
Brief Summary
This study aims to evaluate the efficacy and safety of 14-day quadruple therapy based on fecal molecular antimicrobial susceptibility tests for the first-line eradication of H. pylori infection, thus, providing more evidence to inform the value of fecal antimicrobial susceptibility tests in the first-line treatment of H. pylori infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMay 15, 2023
January 1, 2023
1 year
January 30, 2023
May 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Helicobacter pylori Eradication Rate
Helicobacter pylori Eradication will be determined by 13C-urea breath test or 14C-urea breath test six to eight weeks after completion of the medication.
Six to eight weeks after completion of the medication
Secondary Outcomes (2)
Rate of Adverse Drug Reaction(ADR)
Within 7 days after completion of therapy
Compliance Rate
Within 7 days after completion of therapy
Study Arms (3)
Amoxicillin- and Clarithromycin-based BQT
ACTIVE COMPARATORrabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days
Clarithromycin medication history-based BQT
EXPERIMENTALThe clarithromycin medication history will be asked before the treatment and the therapy will be performed as follows: with clarithromycin medication history: rabeprazole 10mg bid, amoxicillin 1g bid, furazolidone 100mg bid, colloidal bismuth 200mg bid for 14 days; without clarithromycin medication history: rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days.
Antimicrobial susceptibility tests-based BQT
EXPERIMENTALFecal molecular biology antimicrobial susceptibility tests will be performed before the treatment. The susceptibility of clarithromycin will be evaluated. The treatment regimen will be chosen according to the results of the antimicrobial susceptibility tests as follows: clarithromycin-sensitive: rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days; clarithromycin-resistant: rabeprazole 10mg bid, amoxicillin 1g bid, furazolidone 100mg bid, colloidal bismuth 200mg bid for 14 days.
Interventions
proton-pump inhibitor (PPI)
Gastric mucosal protective drug with anti-H. pylori effect
Antibiotic for H. pylori eradication
Antibiotic for H. pylori eradication
Antibiotic for H. pylori eradication
Eligibility Criteria
You may qualify if:
- Participants enrolled should meet the following criteria: (1) Participants aged 18-65 with no history of eradication treatment; (2) diagnosed as H. pylori infection by one or more of the following methodologies: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), the 13C-UBT, and/or fecal antigen; (3) were requested to undergo an endoscopy before the eradication treatment if they have alarm symptoms, a family history of gastric cancer or age over 40 years old without undergoing an endoscopy before; and (4) voluntarily participated in the clinical trial and have signed the informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009, China
Related Publications (2)
Yu Z, Liu X, Qiao J, Shen W, Mao X, Lou G, Li Y, Xie Z, Ye J. Is Tailored Bismuth Quadruple Therapies (With Clarithromycin or Furazolidone) Based on Fecal Molecular Susceptibility Testing in First-Line Helicobacter pylori Eradication Treatment More Effective? A Three-Arm, Multicenter Randomized Clinical Trial. Helicobacter. 2025 Jan-Feb;30(1):e70018. doi: 10.1111/hel.70018.
PMID: 39924352DERIVEDWu Y, Wang Y, Liu X, Liao O, Lou G, Li Y, Wu H, Du Q, Ye J. Efficacy of quadruple therapy with clarithromycin based on faecal molecular antimicrobial susceptibility tests as first-line treatment for Helicobacter pylori infection: a protocol of a single-centre, single-blind, randomised clinical trial in China. BMJ Open. 2023 Jul 21;13(7):e072670. doi: 10.1136/bmjopen-2023-072670.
PMID: 37479526DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qin Du, Master
Second Affiliated Hospital of Zhejiang University, School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2023
First Posted
February 8, 2023
Study Start
March 1, 2023
Primary Completion
March 1, 2024
Study Completion
June 30, 2024
Last Updated
May 15, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- IPD Sharing will be available from June 1st 2024.
- Access Criteria
- Data are available upon reasonable request. Data are available from the corresponding author upon reasonable request.
After the completion of this study, data are available upon reasonable request. Data are available from the corresponding author upon reasonable request.