Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.
This will be a multi-center, open labeled, randomized comparative trial Patients: 240 patients with H. pylori infection who failed after first-line therapy will be eligible
Interventions: eligible patients will be randomized into one of the two groups Group (A): sequential therapy for 14 days (S14)
D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days
D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days
Group (B): bismuth quadruple therapy for 10 days (Q10)
D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Primary End Point: Eradication rate in the second line treatment according to intention to treat (ITT) analysis in the two treatment groups
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential therapy for 14 days | Experimental | Sequential therapy for 14 days (experimental) D1-D7: (Nexium, esomeprazole 40mg bid + amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid) for 7 days D8-D14: (Nexium, esomeprazole 40mg bid + Klaricid XL, clarithromycin 500mg bid + Flagyl, metronidazole 500mg bid) for another 7 days |
|
| bismuth quadruple therapy for 10 days | Active Comparator | Bismuth quadruple therapy for 10 days (active comparator) D1-D10: (Nexium, esomeprazole 40mg bid + KCB F.C. TABLETS, dibismuth trioxide 120mg qid + Flagyl, metronidazole 500mg tid + tetracycline (Brand name: Tetracycline Capsule ) 500mg qid) for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole (S14) | Drug | Nexium, esomeprazole 40mg bid, 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| eradication rate in the second-line treatment according to intention to treat (ITT) analysis | Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Successful eradication of H. pylori will be defined as a negative 13C-UBT result. A positive 13C-UBT test will be defined as a delta value of 4 units or greater. All subjects will be asked to stop PPI and H2-blocker for at least two weeks before 13C-UBT. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse effects in the first line therapy in the two treatment groups | At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events | 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from the study if any one of the following criteria was present:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jyh-Ming Liou, MD, PhD | Contact | 886-2-23123456 | 63541 | jyhmingliou@gmail.com |
| Ming-Shiang Wu, MD, PhD | Contact | 886-2-23123456 | 65043 | mingshiang@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Jyh-Ming Liou, MD, PhD | National Taiwan University Hospital | Study Chair |
| Yu-Jen Fang, MD | National Taiwan University Hospital, Yun-Lin Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jyh-Ming Liou | Recruiting | Taipei, Taiwan | 10002 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27769562 | Result | Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Chen CC, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2016 Nov 12;388(10058):2355-2365. doi: 10.1016/S0140-6736(16)31409-X. Epub 2016 Oct 18. | |
| 23158886 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The technicians who performed the UBT test are blind to the treatment allocation
| Esomeprazole (BQ10) | Drug | Nexium, esomeprazole, 40mg bid for 10 days |
|
|
| Amoxicillin (ST14) | Drug | Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days |
|
|
| Clarithromycin (ST14) | Drug | Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14) |
|
|
| Metronidazole (ST14) | Drug | Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14) |
|
|
| dibismuth trioxide 120mg (BQ10) | Drug | KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days |
|
|
| Metronidazole (BQ10) | Drug | Flagyl, metronidazole 500mg tid for 10 days |
|
|
| tetracycline (BQ10) | Drug | Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days |
|
|
| Eradication rates in the second line treatment according to per protocol (PP) analysis |
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Patients not follow the protocol will be excluded for PP analysis. |
| 6 weeks |
| Changes of gut microbiota in the two treatment groups | the stool specimens before, 2weeks after, 8 weeks after, and 1 year after the treatment will be collected for gut microbiota analysis | 2 weeks, 8 weeks, and 1 year |
| Re-infection rate one year after eradication therapy | Urea breath test will be performed 1 year after the end of eradication therapy. | 1 year |
| Result |
| Liou JM, Chen CC, Chen MJ, Chen CC, Chang CY, Fang YJ, Lee JY, Hsu SJ, Luo JC, Chang WH, Hsu YC, Tseng CH, Tseng PH, Wang HP, Yang UC, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Helicobacter Consortium. Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2013 Jan 19;381(9862):205-13. doi: 10.1016/S0140-6736(12)61579-7. Epub 2012 Nov 16. |
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| C039747 | ribosomal protein S14 |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| D013752 | Tetracycline |
| 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 |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided