Clinical trial NCT05718609: Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection
Official title: Efficacy of Quadruple Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests as First-line Treatment for Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 855
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Helicobacter pylori Eradication Rate
timeFrame: Six to eight weeks after completion of the medication
Secondary outcomes:
measure: Rate of Adverse Drug Reaction(ADR)
timeFrame: Within 7 days after completion of therapy
measure: Compliance Rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University, School of Medicine
name: Qin Du, Master
role: STUDY_CHAIR
References: