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This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) 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 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath 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 12 and 14.
Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| berberine quadruple therapy | Experimental | Berberine 500 mg, esomeprazole 20 mg,amoxicillin 1000 mg, and clarithromycin 500 mg by mouth, twice daily for 14 days. |
|
| bismuth quadruple therapy | Active Comparator | Bismuth 220 mg, esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine | Drug | Berberine-containing quadruple therapy group: given for 14 days at a dose of berberine 100 mg 5 tablets BID, esomeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID. |
| Measure | Description | Time Frame |
|---|---|---|
| helicobacter pylori eradication | The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication. | 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms effective rates | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongquan Shi, Ph. D | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Xi’an | Shanxi | 710032 | China |
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| D010437 | Peptic Ulcer |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D001599 | Berberine |
| D001729 | Bismuth |
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Bismuth | Drug | Bismuth-containing quadruple therapy group: given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID. |
|
|
| esomeprazole | Drug | Esmeprazole 20mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy. |
|
|
| amoxicillin | Drug | Amoxicillin 500 mg 2 capsules BID plus esmeprazole 20mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy. |
|
|
| clarithromycin | Drug | Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 20mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy. |
|
| 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 |
| D004378 |
| Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |