Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Eradication rate
Brief summary
Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.
Detailed description
A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.
Interventions
DRUG(dexlan+amox+clar+metr)+(dexlan+amox)
a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily
DRUGdexlan+clarith+amox+metro
dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 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 or bismuth 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 in Which H. Pylori Was Eradicated | sixth week after the end of anti- H. pylori therapy | To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| (Dexlan+Amox+Clar+Metr)+(Dexlan+Amox) a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily
(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily | 124 |
| Dexlan+Clarith+Amox+Metro dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days
dexlan+clarith+amox+metro: dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days | 124 |
| Total | 248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
Baseline characteristics
| Characteristic | (Dexlan+Amox+Clar+Metr)+(Dexlan+Amox) | Dexlan+Clarith+Amox+Metro | Total |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 12.3 | 54.7 years STANDARD_DEVIATION 11.2 | 55.5 years STANDARD_DEVIATION 11.8 |
| History of smoking | 18 participants | 26 participants | 44 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 124 Participants | 124 Participants | 248 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 124 participants | 124 participants | 248 participants |
| Sex: Female, Male Female | 66 Participants | 64 Participants | 130 Participants |
| Sex: Female, Male Male | 58 Participants | 60 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 124 |
| other Total, other adverse events | 25 / 124 | 48 / 124 |
| serious Total, serious adverse events | 0 / 124 | 0 / 124 |
Outcome results
Primary
Number of Participants in Which H. Pylori Was Eradicated
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.
Time frame: sixth week after the end of anti- H. pylori therapy
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| (Dexlan+Amox+Clar+Metr)+(Dexlan+Amox) | Number of Participants in Which H. Pylori Was Eradicated | 124 participants |
| Dexlan+Clarith+Amox+Metro | Number of Participants in Which H. Pylori Was Eradicated | 121 participants |