Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）

Helicobacter pylori (H. pylori) infection is a common and clinically important condition associated with peptic ulcer disease, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Effective eradication remains essential for reducing long-term complications. Traditional proton pump inhibitor (PPI)-based regimens have faced challenges due to rising antibiotic resistance and suboptimal acid suppression.

Tegoprazan is a potassium-competitive acid blocker (P-CAB) that provides rapid, potent, and sustained gastric acid inhibition, which may enhance the effectiveness of amoxicillin-based dual therapy. Amoxicillin resistance remains low in many regions, and its efficacy is closely related to maintaining intragastric pH levels that support bacterial replication.

The standard tegoprazan dual therapy uses amoxicillin 1 gram three times daily (TID). However, TID dosing may affect patient adherence, which can influence eradication outcomes. This study explores an alternative regimen: amoxicillin 1.5 grams twice daily (BID). The two regimens deliver the same total daily dose of 3 grams of amoxicillin, but the BID schedule may improve convenience and medication compliance while maintaining appropriate pharmacodynamic exposure.

This randomized, controlled clinical trial is designed to compare the eradication efficacy, safety, and tolerability of these two dosing strategies in adults with confirmed H. pylori infection. By evaluating whether a simplified BID regimen can achieve non-inferior or superior eradication rates compared with the standard TID regimen, the study aims to provide evidence that may support more convenient dual therapy options for H. pylori management.

Inclusion criteria

• 1.Adults aged 18 to 70 years. 2.Confirmed Helicobacter pylori infection by ¹³C-urea breath test, stool antigen test, or gastric biopsy.

3.Able to provide written informed consent. 4.Willing and able to comply with all study procedures, including follow-up testing 4-8 weeks after treatment.

Exclusion criteria

• 1.Known allergy or hypersensitivity to tegoprazan, amoxicillin, or any β-lactam antibiotics.

2.Use of antibiotics, proton pump inhibitors (PPIs), bismuth-containing agents, or potassium-competitive acid blockers within 4 weeks before screening.

3.Severe hepatic impairment (ALT or AST > 3 × upper limit of normal). 4.Severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m²).

5.Pregnant or breastfeeding women. 6.History of gastric surgery or conditions that may affect gastrointestinal absorption.

7.Participation in another clinical trial within the past 30 days. 8.Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.