Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Quadruple Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests as First-line Treatment for Helicobacter Pylori Infection

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Rabeprazole
* Drug: Colloidal Bismuth Pectin Granules
* Drug: Amoxicillin
* Drug: Furazolidone
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria: (1) Participants had a history of using antibiotics or bismuth within four weeks or acid inhibitor (including H2 receptor antagonist (H2RA), proton-pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB)) within two weeks before inclusion; (2) had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction; (3) had a history of esophagectomy or gastrectomy; (4) had an allergy to any study drug; (5) were pregnant or breastfeeding; (6) had a history of alcohol abuse or drug addiction; (7) existence of mental illness; or (8) without self-judgment ability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amoxicillin- and Clarithromycin-based BQT<br>rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days | Drug: Rabeprazole<br>* proton-pump inhibitor (PPI)<br>Drug: Colloidal Bismuth Pectin Granules<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: Clarithromycin<br>* Antibiotic for H. pylori eradication<br>|
| Experimental: Clarithromycin medication history-based BQT<br>The 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. | Drug: Rabeprazole<br>* proton-pump inhibitor (PPI)<br>Drug: Colloidal Bismuth Pectin Granules<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: Furazolidone<br>* Antibiotic for H. pylori eradication<br>Drug: Clarithromycin<br>* Antibiotic for H. pylori eradication<br>|
| Experimental: Antimicrobial susceptibility tests-based BQT<br>Fecal 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. | Drug: Rabeprazole<br>* proton-pump inhibitor (PPI)<br>Drug: Colloidal Bismuth Pectin Granules<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: Furazolidone<br>* Antibiotic for H. pylori eradication<br>Drug: Clarithromycin<br>* Antibiotic for H. pylori eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Adverse Drug Reaction(ADR) | 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). | Within 7 days after completion of therapy | 
| Compliance Rate | Compliance was defined as poor when they had taken less than 80% of the total medication. | Within 7 days after completion of therapy |