Helicobacter Pylori Infection Clinical Trial
Official title:
Study on The Efficacy and Safety of Berberine,Amoxicillin and Vonoprazan Containing Triple Therapy in Helicobacter Pylori First-Line Eradication
Verified date | January 2023 |
Source | Xijing Hospital of Digestive Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of berberine, amoxicillin and vonoprazan containing triple therapy in Helicobacter Pylori first-line eradication. It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy or vonoprazan -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.
Status | Completed |
Enrollment | 300 |
Est. completion date | June 30, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Age between 18~70,both gender. 2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment; 3. Patients are willing to receive eradication treatment. 4. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial. Exclusion Criteria: 1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori. 2. Patients with contraindications or allergies to the study drug. 3. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases. 4. 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). 5. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma. 6. Pregnant or lactating women. 7. Underwent upper gastrointestinal Surgery. 8. Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia. 9. Patients have symptom of dysphagia. 10. Evidence of bleeding or iron efficiency anemia. 11. A history of malignancy. 12. Drug or alcohol abuse history in the past 1 year. 13. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 14. Patients who has psychological problem or poor compliance. 15. Enrolled in other clinical trials in the past 3 months. 16. Refuse to sign informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital of Digestive Diseases |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | H pylori eradication rates | 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. | 28 days after treatment | |
Secondary | symptoms effective rate | 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 |
14 days of treatment, and 28 days after treatment | |
Secondary | adverse events | 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. | 14 days of treatment, and 28 days after treatment |
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