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This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.
The trial can be divided into three phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose dual therapy | Experimental | Esomeprazole Enteric Tablets 40mg, 3 times/day; Amoxicillin Capsules 1000mg, 3 times/day.The course of all drugs is two weeks. |
|
| Bismuth Quadruple Therapy | Active Comparator | Esomeprazole Enteric Tablets 40mg, 2 times/day; Amoxicillin Capsules 1000mg, 2 times/day; Clarithromycin Tablets 500mg, 2 times/day; Colloidal Bismuth Tartrate Capsules 220mg, 2 times/day.The course of all drugs is two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | High-dose dual therapy: given for 14 days at a dose of esomeprazole 20mg 2 tablet TID plus amoxicillin 500 mg 2 capsules TID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the diversity and structure of fecal microbiota | Feces from subjects before treatment , after eradication treatment , and at week 6 after eradication treatment were analyzed for gut microbiota diversity by 16S rRNA gene sequencing, including alpha diversity (representing the abundance of species in the microbial ecosystem, i.e., the number of different species, and evenness, i.e., similar abundance or dominance of some species over others) and beta diversity (representing the difference in microbial composition in one environment compared to another).We will explore the changes in intestinal microbiota diversity and structure before and after treatment with both treatment regimens. | before treatment,1day after treatment,6 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of Helicobacter pylori | The end point of this study is H.pylori eradication,established by negative [13C] urea breath test (DOB value below 3.9)28 days after the end of eradication. | 28 days after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongquan Shi, Ph. D | Xijing Hosipital of Digestive Disease | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
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|
| Amoxicillin | Drug | High-dose dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 20mg 2 tablet TID |
|
|
| Bismuth | Drug | Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID |
|
| Esomeprazole | Drug | BBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID |
|
|
| Amoxicillin | Drug | Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID |
|
| Clarithromycin | Drug | Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID |
|
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D004415 | Dyspepsia |
| D013274 | Stomach Neoplasms |
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D001729 | Bismuth |
| D017291 | Clarithromycin |
| 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 |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| 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 |
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