Helicobacter Pylori Infection, Peptic Ulcer
Conditions
Keywords
Peptic ulcer, Helicobacter pylori, Clarithromycin, 23S rRNA, Resistance
Brief summary
1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance 2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully 3. Material & methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.
Interventions
PROCEDURE23S rRNA point mutation test of Helicobacter pylori
mutation test group\>\> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group \>\> no intervention
PROCEDUREUBT test & Gastroenterology with biopsy c silver stain
UBT test & Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group \>\> intervention
Sponsors
Korean College of Helicobacter and Upper Gastrointestinal Research
Jin Il Kim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 20 - 75 years old * Peptic ulcer (gastric ulcer, duodenal ulcer) * Helicobacter pylori positive
Exclusion criteria
* Major comorbidities * Pregnancy * History of Helicobacter pylori eradication * History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter Pylori Eradication Rate | 8 weeks | Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks. |
Countries
South Korea
Participant flow
Recruitment details
five hospitals affiliated with the Catholic University who visited from August 2011 to June 2012
Pre-assignment details
Mutation test group ; Patients which are no detection of H. pyloriare were excluded
Participants by arm
| Arm | Count |
|---|---|
| Convential AOC Group amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks | 308 |
| Mutation Test Group Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week | 218 |
| Convential AOM Group The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks | 308 |
| Total | 834 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 115 | 31 |
Baseline characteristics
| Characteristic | Mutation Test Group | Convential AOM Group | Convential AOC Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 218 Participants | 308 Participants | 308 Participants | 834 Participants |
| Age Continuous | 54.7 years STANDARD_DEVIATION 12.2 | 56.2 years STANDARD_DEVIATION 13.2 | 54.0 years STANDARD_DEVIATION 12 | 54.9 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment Korea, Republic of | 218 participants | 308 participants | 308 participants | 834 participants |
| Sex: Female, Male Female | 49 Participants | 150 Participants | 205 Participants | 404 Participants |
| Sex: Female, Male Male | 169 Participants | 158 Participants | 103 Participants | 430 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 | 0 / 308 | 0 / 308 | 0 / 218 |
| serious Total, serious adverse events | 0 / 308 | 0 / 308 | 0 / 218 |
Outcome results
Primary
Helicobacter Pylori Eradication Rate
Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.
Time frame: 8 weeks
Population: Each convential AOC, AOM group : 308 patients Mutation test gorup : H. pylori was not detected by PCR 90 patient , total 218 patient predicted prevalence - 50%, expected dropout rate -15%, predicted eradication rate - 80%, significance level - 0.05, statistical power - 90%
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Convential AOC Group | Helicobacter Pylori Eradication Rate | 75.9 percentage of participants |
| Mutation Test Group | Helicobacter Pylori Eradication Rate | 91.2 percentage of participants |
| Convential AOM Group | Helicobacter Pylori Eradication Rate | 79.1 percentage of participants |