Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori
Brief summary
1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea. 2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia
Detailed description
Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea. In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.
Interventions
DRUGPantoprazole
Pantoprazole 40mg bid
DRUGAmoxicillin
Amoxicillin 1000mg bid
DRUGClarithromycin
Clarithromycin 500mg bid
DRUGMetronidazole
Metronidazole 500mg tid
DRUGTetracycline
Tetracycline 1000mg bid
DRUGBismuth
Bismuth 600mg bid
Sponsors
SK Chemicals Co., Ltd.
Chong Kun Dang Pharmaceutical
HK inno.N Corporation
Green Cross Corporation
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female Korean Adult (Aged ≥ 18 years) * Patients who diagnosis of H. pylori infection by any of following three methods * positive rapid urease test (CLOtest) * histologic evidence of H. pylori by modified Giemsa staining * positive 13C-urea breath test
Exclusion criteria
* Age under 18 years * Previous eradication treatment for H. pylori * Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics * History of gastrectomy * Advanced gastric cancer or other malignancy * Abnormal liver function or liver cirrhosis * Abnormal renal function or chronic kidney disease * Other severe concurrent diseases * Previous allergic reactions to the study drugs * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Counts of Participants With Successful H. Pylori Eradication | 4 weeks after termination of eradication therapy, up to 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Counts of Participants Whose Drug Compliance is More Than 85% | 4 weeks after termination of eradication therapy, up to 6 weeks |
| Counts of Participants With Adverse Event | 4 weeks after termination of eradication therapy, up to 6 weeks |
| Functional Dyspepsia Symptom Responses Rate | 1 year after termination of eradication therapy |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequential Therapy pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Pantoprazole
Amoxicillin
Clarithromycin
Metronidazole | 195 |
| Modified Bismuth Quadruple Therapy pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Pantoprazole
Amoxicillin
Tetracycline
Bismuth | 195 |
| Total | 390 |
Baseline characteristics
| Characteristic | Modified Bismuth Quadruple Therapy | Sequential Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 41 Participants | 86 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants | 154 Participants | 304 Participants |
| Age, Continuous | 53.6 years STANDARD_DEVIATION 13.2 | 53.1 years STANDARD_DEVIATION 12.6 | 53.4 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment Korea, Republic of | 195 participants | 195 participants | 390 participants |
| Sex: Female, Male Female | 78 Participants | 92 Participants | 170 Participants |
| Sex: Female, Male Male | 117 Participants | 103 Participants | 220 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 93 / 195 | 72 / 195 |
| serious Total, serious adverse events | 0 / 195 | 0 / 195 |
Outcome results
Primary
Counts of Participants With Successful H. Pylori Eradication
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequential Therapy | Counts of Participants With Successful H. Pylori Eradication | 146 Participants |
| Modified Bismuth Quadruple Therapy | Counts of Participants With Successful H. Pylori Eradication | 134 Participants |
Secondary
Counts of Participants Whose Drug Compliance is More Than 85%
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequential Therapy | Counts of Participants Whose Drug Compliance is More Than 85% | 165 Participants |
| Modified Bismuth Quadruple Therapy | Counts of Participants Whose Drug Compliance is More Than 85% | 170 Participants |
Secondary
Counts of Participants With Adverse Event
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequential Therapy | Counts of Participants With Adverse Event | 93 Participants |
| Modified Bismuth Quadruple Therapy | Counts of Participants With Adverse Event | 72 Participants |
Secondary
Functional Dyspepsia Symptom Responses Rate
Time frame: 1 year after termination of eradication therapy
Population: SQT and PBAT were used for the initial treatment. Thereafter, treatment success and treatment failure group were divided. In the treatment failure group, secondary treatment was performed. Secondary endpoints were functional and dyspepsia symptom responses rate after successful treatment, not success in both treatment groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequential Therapy | Functional Dyspepsia Symptom Responses Rate | complete (≥75%) | 44 Participants |
| Sequential Therapy | Functional Dyspepsia Symptom Responses Rate | Satisfactory (50-74%) | 1 Participants |
| Sequential Therapy | Functional Dyspepsia Symptom Responses Rate | Partial (25-49%) | 6 Participants |
| Sequential Therapy | Functional Dyspepsia Symptom Responses Rate | Refractory (<25%) | 9 Participants |
| Modified Bismuth Quadruple Therapy | Functional Dyspepsia Symptom Responses Rate | Refractory (<25%) | 2 Participants |
| Modified Bismuth Quadruple Therapy | Functional Dyspepsia Symptom Responses Rate | complete (≥75%) | 0 Participants |
| Modified Bismuth Quadruple Therapy | Functional Dyspepsia Symptom Responses Rate | Partial (25-49%) | 1 Participants |
| Modified Bismuth Quadruple Therapy | Functional Dyspepsia Symptom Responses Rate | Satisfactory (50-74%) | 0 Participants |