Helicobacter Pylori Infection
Conditions
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.
Detailed description
The eradication rate of H. pylori is decreasing year by year due to the occurrence of bacterial resistance, especially clarithromycin, one of the most widely-used antimicrobials against H. pylori. Understanding antibiotic resistance before treatment may be the main determinant of the successful eradication of H. pylori. Nevertheless, due to the invasive examination of sampling, the economy-benefit ratio, and the harsh cultivation conditions, traditional antimicrobial susceptibility test is rarely used before first-line eradication treatment in the real world. As an alternative, faster and simpler molecular methods applied to fecal samples obviate the need for endoscopy and provide the possibility to popularize the antimicrobial susceptibility tests catering to initial treatment. This study aims to explore the efficacy, safety, and economic benefits of the first-line therapy for H. pylori guided by fecal antimicrobial susceptibility tests.
Interventions
DRUGRabeprazole
proton-pump inhibitor (PPI)
DRUGColloidal Bismuth Pectin Granules
Gastric mucosal protective drug with anti-H. pylori effect
DRUGAmoxicillin
Antibiotic for H. pylori eradication
DRUGFurazolidone
Antibiotic for H. pylori eradication
DRUGClarithromycin
Antibiotic for H. pylori eradication
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Potential participants will be screened on the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori Eradication Rate | Six to eight weeks after completion of the medication | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Drug Reaction(ADR) | Within 7 days after completion of therapy | Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). |
| Compliance Rate | Within 7 days after completion of therapy | Compliance was defined as poor when they had taken less than 80% of the total medication. |
Countries
China
Contacts
Primary ContactQin Du, Master
Outcome results
None listed