ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION

NCT ID: NCT03968302

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-05-15

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.

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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM A

The triple regimen, amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole 40 mg twice a day

Group Type: EXPERIMENTAL

ARM A Triple therapy for helicobacter pylori

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

ARM B Quadruple therapy for helicobacter pylori

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ziauddin University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Asim

GI FELLOW

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MUHAMMAD ASIM, MBBS

Role: PRINCIPAL_INVESTIGATOR

ZIAUDDIN UNIVERSITY HOSPITAL

KHURRAM BAQAI, FCPS

Role: PRINCIPAL_INVESTIGATOR

Ziauddin University

ZAIGHAM ABBAS, FCPS

Role: STUDY_CHAIR

Ziauddin University

Locations

Ziauddin University Hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

ZiauddinU

Identifier Type: -

Identifier Source: org_study_id