Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine-containing triple therapy | Experimental | vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days. |
|
| Bismuth-containing quadruple therapy | Active Comparator | Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. |
|
| vonoprazan-containing quadruple therapy | Active Comparator | Bismuth potassium citrate 220 mg, vonoprazan 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine | Drug | berberine 500 mg, twice daily for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vonoprazan |
| Drug |
Vonoprazan 20 mg, twice daily for 14 days |
|
| Amoxicillin | Drug | amoxicillin 1000mg, twice daily for 14 days. |
|
| Rabeprazole | Drug | Rabeprazole 10mg, twice daily for 14 days. |
|
| Bismuth | Drug | Bismuth 220mg, twice daily for 14 days. |
|
| Clarithromycin | Drug | clarithromy 500mg, twice daily for 14 days. |
|
| 14 days of treatment, and 28 days after treatment |
| 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 |
| ID | Term |
|---|---|
| D001599 | Berberine |
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D000658 | Amoxicillin |
| D064750 | Rabeprazole |
| D001729 | Bismuth |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
Not provided
Not provided