Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication
- Conditions
- Helicobacter Pylori InfectionChronic Gastritis
- Interventions
- Registration Number
- NCT06514274
- Lead Sponsor
- Xijing Hospital of Digestive Diseases
- Brief Summary
The purpose of this study was to evaluate the efficacy and safety of the triple therapy of berberine hydrochloride, vonorasan and amoxicillin for the primary eradication of Helicobacter pylori.It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
- Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 558
- Age between 18~70,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
- Patients are willing to receive eradication treatment.
- Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
- Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- Patients with contraindications or allergies to the study drug.
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
- Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
- Patients have symptom of dysphagia.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Drug or alcohol abuse history in the past 1 year.
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- Patients who has psychological problem or poor compliance.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bismuth-containing quadruple therapy Bismuth Bismuth potassium citrate 220 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. Berberine-containing triple therapy Berberine vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days. Berberine-containing triple therapy Vonoprazan vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days. Berberine-containing triple therapy Amoxicillin vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days. Bismuth-containing quadruple therapy Amoxicillin Bismuth potassium citrate 220 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. Bismuth-containing quadruple therapy Clarithromycin Bismuth potassium citrate 220 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. Bismuth-containing quadruple therapy Esomeprazole Bismuth potassium citrate 220 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
- Primary Outcome Measures
Name Time Method H pylori eradication rates 28 days after treatment The primary end point of this study is H.pylori eradication,established by negative urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.
- Secondary Outcome Measures
Name Time Method adverse events 14 days of treatment, and 28 days after treatment Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.
symptoms effective rate 14 days of treatment, and 28 days after treatment Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment.
Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%.
Total score = frequency + severity.
Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence.
Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe
Trial Locations
- Locations (1)
Xijing Hosipital of Digestive Disease
🇨🇳Xi'an, Shaanxi, China