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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
| General Hospital of Jinan Military Region | UNKNOWN |
| Binzhou People's Hospital | OTHER |
| Liaocheng People's Hospital |
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Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clarithromycin dependant group | Experimental | Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin. If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen. |
|
| 6 antibiotics dependant group | Experimental | Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. |
|
| salvage therapy for negative culture | Other | when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarithromycin susceptibility dependant strategy | Drug | Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin. If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen. |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rates in 2 groups | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of improving dyspepsia symptoms after H. pylori eradication | 6 months | |
| the rate of adverse events happening | 6 months | |
| the rate of good compliance (take pills more than 90%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Yanqing, MD, PhD | Contact | 86-531-82169236 | liyanqing@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Yanqing, MD, PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Recruiting | Ji'nan | Shandong | 250012 | China |
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| OTHER |
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|
| salvage therapy for failed eradication | Other | If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d. |
|
|
| 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ) | Drug | Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. |
|
| proton pump inhibitor (PPI) and Colloidal Bismuth Pectin | Drug | all patients need these two drugs. |
|
| amoxicillin and clarithromycin or amoxicillin and furazolidone | Drug | patients in the 6 antibiotics dependant group will use these intervention. |
|
| amoxicillin and furazolidone or amoxicillin and tetracycline | Drug | salvage therapy for negative culture when the results of culture are negative |
|
| amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin | Drug | salvage therapy for failed eradication if failed with AST guided eradication therapy |
|
| 5 months |
| difference of cost per patient for each eradication achieved in 2 groups | 6 months |
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| D014011 | Tinidazole |
| D064704 | Levofloxacin |
| D005664 | Furazolidone |
| D013752 | Tetracycline |
| D054328 | Proton Pump Inhibitors |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D009581 | Nitrofurans |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D005663 | Furans |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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