Amoxicillin 1 g TID: Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.
Amoxicillin 1.5 g BID: Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.
Study summary
This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin.
One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount.
A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
H. pylori Eradication Rate — 4 to 8 weeks after completion of therapy Eradication of Helicobacter pylori infection confirmed by a negative ¹³C-urea breath test performed 4 to 8 weeks after the end of the 14-day treatment regimen.
Trial sites (1)
Facility
City
Region
Status
Hangzhou First People's Hospital
Hangzhou
Zhejiang
More First People's Hospital of Hangzhou trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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