| Eligibility |
Inclusion Criteria:
- Voluntarily sign the informed consent form.
- Age 18-65 years (inclusive), male or female.
- The result of 13C-UBT is positive (= 4 Delta Over Baseline), and the infection of H.
pylori are confirmed by gastroscopic biopsy histology.
- Subjects agree to refrain from taking any antibiotics or traditional Chinese medicines
with antibacterial effect, bismuth, and antacids (such as PPI, H2 receptor blocker,
P-CAB) other than the study drugs during the Screening Period until the end of the
study (Visit 5, i.e., Efficacy Evaluation Visit).
- Subjects and their heterosexual partners must agree to have no pregnancy plan and
voluntarily take effective contraceptive measures during the trial and for at least 6
months after the end of the study medication.
- Willing to follow and able to complete all trial procedures.
Exclusion Criteria:
- Allergy to any of the study drugs (rabeprazole, amoxicillin, clarithromycin, bismuth
potassium citrate), allergic constitution (multiple drug and food allergies); or any
contraindication to the use of rifamycin, nitroimidazoles or study drugs.
- History of H. pylori eradication therapy (including participation in other clinical
trials for H. pylori eradication).
- Subjects with confirmed tuberculosis (TB) or Mycobacterium avium complex (MAC)
infection or a history of TB or MAC infection.
- History of dysphagia or any gastrointestinal disorder affecting drug absorption.
- History of obstruction pyloric; or excessive gastric acid secretion (such as
Zollinger-Ellison syndrome).
- History of gastric cancer.
- History of neoplasm malignant within 5 years prior to screening, with the exception of
basal cell carcinoma or carcinoma cervix in situ treated without evidence of
recurrence.
- History of esophageal or gastric surgery, except for simple repair of the perforated
ulcer.
- History of substance abuse or drug use within 5 years prior to screening.
- Alcohol abuse or a history of alcohol abuse within 5 years prior to screening (average
weekly consumption of = 14 units of alcohol: 1 unit = 285 mL of beer, or 25 mL of
spirits, or 100 mL of wine/Chinese rice wine/rice wine);
- Presence of active gastric and/or duodenal ulcer.
- Anticoagulant therapy or long-term treatment with nonsteroidal anti-inflammatory
drugs.
- Treatment with any other investigational new drugs within 4 weeks prior to the
Screening Period.
- Any prohibited medications or non-drug therapies as specified in the protocol (see
Section 10.3).
- White blood cell count or neutrophil count below the lower limit of normal range.
- Anemia (hemoglobin < 90 g/L).
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, or
serum creatinine above the upper limit of normal range.
- Test positive for hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, or
microspironema pallidum antibody.
- Abnormal ECG with clinical significance.
- Female subjects who are pregnant, lactating, or have a positive urine pregnancy result
during the Screening Period.
- Inability to communicate with the Investigator and to comply with the study
requirements.
- Other conditions considered inappropriate to participate in this study by the
Investigator, e.g., the subject has a history of severe central nervous system,
cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological,
endocrine, or hematological diseases, or has clinical manifestations of these
diseases.
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