H Pylori Infection Clinical Trial
Official title:
Comparison of Genotypic Resistance Guided Versus Susceptibility Testing Guided Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial
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.
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
;
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