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The purpose of this study is to assess and compare the effectiveness and safety of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients for eradicating H.pylori.
Helicobacter pylori plays an important role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori remains high in developing countries,including China.
Clarithromycin-containing bismuth quadruple therapy has been recommended as the first-line therapy for H pylori infection in China. However, its expensive cost and high antibiotic-related adverse reactions are always haunting us. In 2018,a research from NanFang hospital(China)revealed that 250mg clarithromycin is as effective as 500mg clarithromycin,at the same time,causes less adverse reactions. On the othe hand,previous studies reported a new regimen called large dose dual therapy(generally contains a PPI and amoxicillin),while some of them have achieved very good results,especially in Taiwan.
However, specific data on anti-H.pylori treatments in elderly people are very lacking.So,we aim to assess and compare the effectiveness and tolerability of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients.Considering the difference of drug metabolism between eldery and young people,a satisfactory result may be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose dual group | Experimental | Patients in high dose dual group will receive lansoprazole (Takepron) 30mg po qid, amoxicillin 750mg po qid for 14d |
|
| half-dose clarithromycin-containing bismuth quadruple group | Active Comparator | Patients in half-dose clarithromycin-containing bismuth quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 250mg po bid for 14d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole, Amoxicillin | Drug | high dose dual regimen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| eradication rate of the two groups | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuli Zuo, MD,PhD | Contact | 15588818685 | 15588818685 | zuoxiuli@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zuo, MD,PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hosipital | Jinan | Shandong | 257000 | China |
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| Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate |
| Drug |
half-dose clarithromycin-containing bismuth quadruple regimen |
|
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| C002791 | bismuth tripotassium dicitrate |
| ID | Term |
|---|---|
| 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 |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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