Helicobacter Pylori Infection Clinical Trial
Official title:
ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION: A RANDOMIZED CONTROLLED STUDY
H pylori is an important cause of chronic gastritis and other complications. There is a
decline in eradication rate for H pylori owing to multiple factors including drug resistance.
We compare the effect of the addition of bismuth to the standard triple therapy in a
randomized control trial.
Subjects were randomized into two arms. Arm A received triple therapy including amoxicillin,
clarithromycin, and omeprazole and Arm B received quadruple therapy adding colloidal bismuth
subcitrate. Both arms received treatment for two weeks.
The study is a 2-arm, prospective, randomized, non-inferiority, unblinded, parallel design
trial. The primary end point is post-treatment result after triple or quadruple therapy.
Secondary endpoints included the nature and frequency of side effects compared between the
two arms. The study protocol was approved by the ethical review committee of the university.
Patients with dyspeptic symptoms who had H pylori infection, diagnosed through positive Stool
for H pylori antigen or presence of H. pylori organism in the histopathology of gastric
mucosal biopsy, attending outpatient department of two campuses of the University Hospital
were included in this study.. Group A received standard triple therapy for H. pylori
eradication for a total 14 days and group B received bismuth-based quadruple therapy for H
pylori eradication for the same period. The triple regimen was defined as a combination of
amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40
mg twice a day dose. Quadruple therapy included colloidal bismuth subcitrate 240 mg twice
daily, in addition. H. Pylori status was checked routinely after 6 weeks by Stool sampling
for H, pylori antigen. Subjects were counseled to stop taking PPI or any antibiotic 2 weeks
before stool H. pylori antigen testing. Eradication of H pylori was defined as lack of
detection of H pylori antigen in the stool via ELISA method after triple or quadruple
therapy.
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