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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718609
• Other study ID #: 2022-1108
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qin Du, Master
• Phone: +86 0571-89713734
• Email: duq518[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 855
• Est. completion date: June 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Rabeprazole
proton-pump inhibitor (PPI)
• Colloidal Bismuth Pectin Granules
Gastric mucosal protective drug with anti-H. pylori effect
• Amoxicillin
Antibiotic for H. pylori eradication
• Furazolidone
Antibiotic for H. pylori eradication
• Clarithromycin
Antibiotic for H. pylori eradication

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University, School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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