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This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth,esomeprazole,tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
The study will include three phases: screening, treatment and follow-up.
Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test,rapid urease test or helicobacter pylori stool antigen test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose esomeprazole and amoxicillin dual therapy | Experimental | Esomeprazole 40 mg and amoxicillin 1000 mg by mouth,three time daily for 14 days |
|
| Bismuth-containing quadruple therapy | Active Comparator | Tetracycline 500mg three time daily for 14 days,furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet TID plus amoxicillin 500 mg 2 capsules TID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication | The primary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms effective rates | symptoms improvement rates Evaluation improvement rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom improvement rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence, etc. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36193978 | Derived | Bi H, Chen X, Chen Y, Zhao X, Wang S, Wang J, Lyu T, Han S, Lin T, Li M, Yuan D, Liu J, Shi Y. Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial. Chin Med J (Engl). 2022 Jul 20;135(14):1707-1715. doi: 10.1097/CM9.0000000000002289. |
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|
| Amoxicillin | Drug | High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 40mg 1 tablet TID |
|
|
| Bismuth | Drug | Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 40 mg 1 tablets BID,tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID |
|
| Esomeprazole | Drug | Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet BID plus bismuth 110 mg 2 capsules BID,tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID |
|
|
| Tetracycline | Drug | Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID,esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID |
|
| Furazolidone | Drug | Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID,esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID |
|
| 14 days of treatment, and 28 days after treatment |
| adverse events | Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain. | 14 days of treatment, and 28 days after treatment |
| 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 |
| D013752 | Tetracycline |
| D005664 | Furazolidone |
| 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 |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D005663 | Furans |
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