Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori infection
Brief summary
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.
Detailed description
The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan. A total of 306 subjects are enrolled into this study. H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.
Interventions
DRUG7-day quadruple therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
DRUG10-day sequential therapy
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
DRUG7-day standard triple therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion criteria
* previous H. pylori-eradication therapy * ingestion of antibiotics, bismuth, or proton pump inhibitors within the prior 4 weeks * patients with allergic history to the medications used * patients with previous gastric surgery * the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Eradication of Helicobacter Pylori | at the 6th week after the end of anti- H. pylori therapy | Evaluate eradication outcome by endoscopy urease test and histology or urea breath test |
Countries
Taiwan
Participant flow
Recruitment details
We surveyed patients who visited the gastroenterological clinic of Kaohsiung Medical University Hospital (KMUH), Kaohsiung Veteran General Hospital (KVGH). A total of 307 H. pylori-infected patients were randomly assigned to triple (n=103 ) or sequential (n = 102) or concomitant (n = 102) therapies.
Participants by arm
| Arm | Count |
|---|---|
| 7-day Quadruple Therapy pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days | 102 |
| 10-day Sequential Therapy pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days | 102 |
| 7-day Standard Triple Therapy pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days | 103 |
| Total | 307 |
Baseline characteristics
| Characteristic | 10-day Sequential Therapy | 7-day Standard Triple Therapy | 7-day Quadruple Therapy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 34 Participants | 28 Participants | 96 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 69 Participants | 74 Participants | 211 Participants |
| Age, Continuous | 54.96 years STANDARD_DEVIATION 12 | 56.08 years STANDARD_DEVIATION 14 | 53.85 years STANDARD_DEVIATION 12.31 | 54.88 years STANDARD_DEVIATION 12.73 |
| Region of Enrollment Taiwan | 102 participants | 103 participants | 102 participants | 307 participants |
| Sex: Female, Male Female | 50 Participants | 41 Participants | 41 Participants | 132 Participants |
| Sex: Female, Male Male | 52 Participants | 62 Participants | 61 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 102 | 9 / 102 | 9 / 103 |
| serious Total, serious adverse events | 0 / 102 | 0 / 102 | 0 / 103 |
Outcome results
Primary
Number of Participants With Complete Eradication of Helicobacter Pylori
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Time frame: at the 6th week after the end of anti- H. pylori therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7-day Quadruple Therapy | Number of Participants With Complete Eradication of Helicobacter Pylori | 102 participants |
| 10-day Sequential Therapy | Number of Participants With Complete Eradication of Helicobacter Pylori | 100 participants |
| 7-day Standard Triple Therapy | Number of Participants With Complete Eradication of Helicobacter Pylori | 101 participants |