HELICOBACTER PYLORI INFECTIONS
Conditions
Keywords
Helicobacter pylori, H. pylori, Amoxicillin, Tegoprazan, Dual Therapy, BID Dosing, TID Dosing, Fixed-Dose Regimen, P-CAB, Frequency Comparison, Antibiotic Regimen Optimization
Brief 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.
Detailed description
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.
Interventions
DRUGTegoprazan 50 mg
Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.
DRUGAmoxicillin 1 g TID
Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.
DRUGAmoxicillin 1.5 g BID
Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label trial. Masking is not feasible because the two study arms use different dosing frequencies (BID vs TID), which cannot be blinded to participants or study personnel.
Intervention model description
This is a randomized, two-arm, parallel-group study in which participants are allocated in a 1:1 ratio to receive tegoprazan plus amoxicillin 1 g TID or tegoprazan plus amoxicillin 1.5 g BID for 14 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | From Day 1 to Day 14 (treatment period) | The number and proportion of participants reporting any adverse events during the 14-day treatment period, assessed by patient report, clinical evaluation, and laboratory findings. |
| Incidence of Serious Adverse Events (SAEs) | From Day 1 to study completion (approximately 8-10 weeks) | Serious adverse events, defined according to standard regulatory criteria (life-threatening events, hospitalization, significant disability, or other medically significant events). |
| Medication Adherence Rate | Day 1 to Day 14 | Adherence assessed by pill count and participant self-report. Adherence will be expressed as the percentage of prescribed doses actually taken during the 14-day treatment period. |
| Change in Gastrointestinal Symptom Scores | Baseline to Day 14 | Improvement in gastrointestinal symptoms (such as epigastric discomfort, bloating, nausea), assessed using a standardized symptom questionnaire. Higher scores indicate more severe symptoms. |
Countries
China
Contacts
Primary ContactHongzhang Shen, PhD/MD
Outcome results
None listed