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Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual therapy | Active Comparator | Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days |
|
| Metronidazole plus dual therapy | Experimental | Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | Proton pump inhibitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value) | Six weeks after completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse effects | The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities) | Within 7 days after completion of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Lu, M.D.,Ph.D. | Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36719104 | Derived | Ding ZH, Huang Y, Chen JN, Luo LS, Zhang W, Liang X, Lu H. A randomized superiority clinical trial: metronidazole improved the efficacy of high-dose dual therapy in Helicobacter pylori rescue treatment. J Antimicrob Chemother. 2023 Mar 2;78(3):828-831. doi: 10.1093/jac/dkad020. |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Amoxicillin |
| Drug |
Antibiotic for H. pylori eradication |
|
| Metronidazole | Drug | Antibiotic for H. pylori eradication |
|
| Compliance rate | Compliance was defined as poor when they had taken less than 80% of the total medication | Within 7 days after completion of therapy |
| 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 |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |