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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05718609

Collaborator

(none)

855

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

50.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Rabeprazole Drug: Colloidal Bismuth Pectin Granules Drug: Amoxicillin Drug: Furazolidone Drug: Clarithromycin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

855 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Amoxicillin- and Clarithromycin-based BQT

rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days

Drug: Rabeprazole

proton-pump inhibitor (PPI)

Drug: Colloidal Bismuth Pectin Granules

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Drug: Clarithromycin

Antibiotic for H. pylori eradication

Experimental: Clarithromycin medication history-based BQT

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

proton-pump inhibitor (PPI)

Drug: Colloidal Bismuth Pectin Granules

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Drug: Furazolidone

Antibiotic for H. pylori eradication

Drug: Clarithromycin

Antibiotic for H. pylori eradication

Experimental: Antimicrobial susceptibility tests-based BQT

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

proton-pump inhibitor (PPI)

Drug: Colloidal Bismuth Pectin Granules

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Drug: Furazolidone

Antibiotic for H. pylori eradication

Drug: Clarithromycin

Antibiotic for H. pylori eradication

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹⁴C-urea breath test, HE stain, or bacterium culture
With no historical treatment for helicobacter pylori infection
Have undergone 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

Exclusion Criteria:

Administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor, and potassium-competitive acid blocker in 2 weeks prior to inclusion
Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.
With previous esophageal or gastric surgery
With severe systemic diseases, major organs like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor, or other diseases
Allergy to any of the study drugs
Pregnancy or lactation
Participated in other research within 3 months, cannot express his/her own ideas correctly or cannot cooperate with the researcher