ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION
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|ClinicalTrials.gov Identifier: NCT03968302|
Recruitment Status : Completed
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: ARM A Triple therapy for helicobacter pylori Drug: ARM B Quadruple therapy for helicobacter pylori||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||PARALLEL ASSIGNMENT|
|Masking:||None (Open Label)|
|Official Title:||ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION: A RANDOMIZED CONTROLLED STUDY|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||May 15, 2019|
|Actual Study Completion Date :||May 15, 2019|
Experimental: ARM A
The triple regimen, amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole 40 mg twice a day
Drug: ARM A Triple therapy for helicobacter pylori
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.
Experimental: ARM B
The quadruple regimen,amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day, omeprazole 40 mg twice a day dose and colloidal bismuth subcitrate 240 mg twice daily
Drug: ARM B Quadruple therapy for helicobacter pylori
Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily,amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.
- POST H PYLORI TREATMENT RESULTS [ Time Frame: 2 months ]The primary end point was post-treatment result after triple or quadruple therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968302
|Ziauddin University Hospital|
|Karachi, Sind, Pakistan|
|Principal Investigator:||MUHAMMAD ASIM, MBBS||ZIAUDDIN UNIVERSITY HOSPITAL|
|Principal Investigator:||KHURRAM BAQAI, FCPS||Ziauddin University|
|Study Chair:||ZAIGHAM ABBAS, FCPS||Ziauddin University|