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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
Sponsor:
Information provided by (Responsible Party):
Muhammad Asim, Ziauddin University

Brief Summary:

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

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PARALLEL ASSIGNMENT
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. POST H PYLORI TREATMENT RESULTS [ Time Frame: 2 months ]
    The primary end point was post-treatment result after triple or quadruple therapy



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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria were patients with age less than 12 years, age more than 80 years, recent antibiotic use, and treatment-experienced patients, where H. pylori couldn't eradicate after treatment, chronic illnesses with multiple comorbid for example, chronic liver disease, chronic kidney disease or terminal illness etc, pregnancy and allergy to any of the regimen components.


Information from the National Library of Medicine

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


Locations
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Pakistan
Ziauddin University Hospital
Karachi, Sind, Pakistan
Sponsors and Collaborators
Ziauddin University
Investigators
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Principal Investigator: MUHAMMAD ASIM, MBBS ZIAUDDIN UNIVERSITY HOSPITAL
Principal Investigator: KHURRAM BAQAI, FCPS Ziauddin University
Study Chair: ZAIGHAM ABBAS, FCPS Ziauddin University

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Responsible Party: Muhammad Asim, GI FELLOW, Ziauddin University
ClinicalTrials.gov Identifier: NCT03968302     History of Changes
Other Study ID Numbers: ZiauddinU
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Muhammad Asim, Ziauddin University:
H pylori; eradication; amoxicillin; clarithromycin; esomeprazole; colloidal bismuth subcitrate
Additional relevant MeSH terms:
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Omeprazole
Amoxicillin
Clarithromycin
Bismuth tripotassium dicitrate
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids