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The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.
The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group:Minocycline+Berberine quadruple therapy | Experimental | 40mg of esomeprazole, 220mg of colloidal bismuth tartrate, 500mg of berberine hydrochloride, and 100mg of minocycline, taken orally twice daily for 14 days. |
|
| control group:Amoxicillin+clarithromycin quadruple | Active Comparator | 40mg of esomeprazole, 220mg of bismuth tartrate colloid, 500mg of clarithromycin, and 1000mg of amoxicillin, taken orally twice a day for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole | Drug | Esomeprazole 40mg, 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yongquan shi, Ph. D | Contact | 86-29-84771515 | shiyquan@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| Bismuth | Drug | Bismuth 220mg, twice daily for 14 days. |
|
| Amoxicillin | Drug | Amoxicillin 1000mg, twice daily for 14 days. |
|
| clarithromycin | Drug | clarithromycin 500mg, twice daily for 14 days. |
|
| Berberine | Drug | Berberine 500 mg, twice daily for 14 days |
|
| Minocycline | Drug | Minocycline 100 mg, twice daily for 14 days |
|
| 14 days of treatment, and 28 days after treatment |
| ID | Term |
|---|---|
| C562573 | cyclopia sequence |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D001729 | Bismuth |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D001599 | Berberine |
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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