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
Not provided
The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline group A | Experimental | Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg tid, Metronidazole 400mg tid |
|
| Minocycline group B | Experimental | Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg qid |
|
| Minocycline group C | Experimental | Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg tid |
|
| Tetracycline group | Active Comparator | Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Potassium competitive acid blocker |
|
| 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). In addition, blood test were messured to access function of liver and kidney. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China | ||
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University |
Not provided
| ID | Term |
|---|---|
| C562573 | cyclopia sequence |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D013752 | Tetracycline |
| D008795 | Metronidazole |
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bismuth Potassium Citrate | Drug | Gastric mucosal protective drug with anti-H. pylori effect |
|
| Tetracycline,Metronidazole | Drug | Antibiotics for H. pylori eradication |
|
| Minocycline,Metronidazole | Drug | Antibiotics for H. pylori eradication |
|
| Within 7 days after completion of therapy |
| 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 |
| Shanghai |
| Shanghai Municipality |
| 200127 |
| China |
| Songjiang Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | China |
| The Second Affiliated Hospital of Zhejiang University school of Medicine | Hangzhou | Zhejiang | China |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |