H Pylori Infection
Conditions
Brief summary
The inviestigators aimed to compare the efficacy of genotypic resistance guided versus susceptibility testing guided therapy in the third line treatment for refractory H. pylori infection. Hypothesis:The investigators hypothesized that genotypic resistance guided sequential therapy is non-inferior to empiric therapy in the third line treatment for refractory H. pylori infection. Methods: This multicenter, open label, parallel group, randomized trial will be conducted since 2017.07.20. Adult (≥20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled. Genotypic and phenotypic resistances will be determined in patients who failed from at least two eradication therapies by polymerase-chain-reaction with direct sequencing and E-test and agar dilution test, respectively. Eligible patients will be randomized into either one of the treatment groups (A) genotypic resistance guided therapy; or (B) susceptibility testing guided therapy. Outcome Measurement The primary outcome is the eradication rate in the third line treatment (genotypic versus susceptibility testing guided therapy) according to intention-to-treat (ITT) analysis.
Detailed description
The inviestigators aimed to compare the efficacy of genotypic resistance guided versus susceptibility testing guided therapy in the third line treatment for refractory H. pylori infection. Hypothesis:The investigators hypothesized that genotypic resistance guided sequential therapy is non-inferior to empiric therapy in the third line treatment for refractory H. pylori infection. Methods: This multicenter, open label, parallel group, randomized trial will be conducted since 2017.07.20. Adult (≥20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled. Genotypic and phenotypic resistances will be determined in patients who failed from at least two eradication therapies by polymerase-chain-reaction with direct sequencing and E-test and agar dilution test, respectively. Eligible patients will be randomized into either one of the treatment groups (A) genotypic resistance guided therapy; or (B) susceptibility testing guided therapy. Eradication status will be determined by 13C-urea breath test at least 6 weeks after eradication therapy. The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut flora. The body weight, waist and hip circumference and serum lipid profile, sugar, and HbA1C levels will also be collected before and 2 weeks, 8 weeks and 1 year after eradication therapy. Outcome Measurement The primary outcome is the eradication rate in the third line treatment (genotypic versus susceptibility testing guided therapy) according to intention-to-treat (ITT) analysis. Secondary End Points: the eradication rate according per protocol analysis and the adverse effects Secondary End Point: (A) Eradication rate according to per protocol analysis (PP analysis) (B) Frequency of adverse effects (C) The changes in the gut microbiota, antibiotic resistance of the Enterobacteriae, metabolic parameters before and after H. pylori eradication (D) The long term eradication rate and reinfection rate
Interventions
DRUGEsomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 14 days
DRUGAmoxicillin
amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)
DRUGmetronidazole
metronidazole, 500mg, bid, for 7 days (day 8-14)
levofloxacin 250mg, bid, for 7 days (day 8-14)
DRUGClarithromycin ER
clarithromycin 500mg, bid, for 7 days (day 8-14)
DRUGDibismuth trioxide
Dibismuth trioxide，KCB F.C. TABLETS，300mg，qid, for 10 days
DRUGtetracycline
tetracycline 500mg, qid, for 10 days
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* H pylori infection failed after at least two eradication therapies * aged 20 years or greater * willingness to receive rescue therapy
Exclusion criteria
* aged less than 20 years * history of gastric resection surgery * history of allergy to study drugs * pregnancy or lactating women * severe underlying illness, such as end stage renal disease, decompensated liver cirrhosis, or non-curative malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication rate by intention to treat analysis | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate by per protocol analysis | 8 weeks | — |
| frequency of adverse effects during eradication therapy | 2 weeks | — |
| changes of fecal microbiota | 1 year | changes of fecal microbiota before and after erdication therapy |
| reinfection rate | 1 year | reinfection rate 1 year after eradication therapy |
Countries
Taiwan
Contacts
Primary ContactJyh-Ming Liou, MD, PhD
Backup ContactMei-Jyh Chen, MD
Outcome results
None listed