Helicobacter pylori infection
Conditions
Interventions
Group B (Novel TD Dual Therapy):Tegoprazan 50 mg twice daily + Doxycycline 100 mg twice daily for 14 days.
Group A (High-dose TA Dual Therapy):Tegoprazan 50 mg twice daily + Amoxicillin 1.0 g three times daily for 14 days.
Group C (Control/Bismuth Quadruple Therapy):Tegoprazan 20 mg twice daily + Bismuth potassium citrate 220 mg twice daily + Amoxicillin 1.0 g twice daily + Doxycycline 100 mg twice daily for 14 days
Sponsors
Shenzhen Nanshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years. 2. Confirmed active H. pyloriinfection by 13C-urea breath test or gastric histopathology. 3. Treatment-naïve patients (first-time eradication therapy);
Exclusion criteria
Exclusion criteria: 1. Allergy to any study drugs (e.g., tegoprazan, penicillins, tetracyclines, macrolides, bismuth). 2. Grade 3 or higher abnormalities per CTCAE v6.0, e.g., ALT >5.0–20.0 times the upper limit of normal (if baseline is normal or below normal) or >2.0–4.0 times baseline (if baseline is >1–5 times the upper limit of normal). 3. Pregnant or lactating women. 4. Use of PPIs, antibiotics, or bismuth within the past 4 weeks. 5. Presence of psychiatric disorders or cognitive impairment preventing study compliance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom Improvement;13C-urea breath test (13C-UBT); | — |
Countries
China
Contacts
Public ContactLuo Qingtian
Shenzhen Nanshan People's Hospital
Outcome results
None listed