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

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.

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

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to 65 Years

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.

• Results publication: Yu Z, Liu X, Qiao J, Shen W, Mao X, Lou G, Li Y, Xie Z, Ye J. Is Tailored Bismuth Quadruple Therapies (With Clarithromycin or Furazolidone) Based on Fecal Molecular Susceptibility Testing in First-Line Helicobacter pylori Eradication Treatment More Effective? A Three-Arm, Multicenter Randomized Clinical Trial. Helicobacter. 2025 Jan-Feb;30(1):e70018. doi: 10.1111/hel.70018. PMID 39924352
• Results publication: Wu Y, Wang Y, Liu X, Liao O, Lou G, Li Y, Wu H, Du Q, Ye J. Efficacy of quadruple therapy with clarithromycin based on faecal molecular antimicrobial susceptibility tests as first-line treatment for Helicobacter pylori infection: a protocol of a single-centre, single-blind, randomised clinical trial in China. BMJ Open. 2023 Jul 21;13(7):e072670. doi: 10.1136/bmjopen-2023-072670. PMID 37479526

• Qin Du, Master, Study chair, Second Affiliated Hospital of Zhejiang University, School of Medicine