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

NCT03968302 | Completed Phase 2 DMC

• 1 other identifier: ZiauddinU
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

H pylori; eradication; amoxicillin; clarithromycin; esomeprazole; colloidal bismuth subcitrate

Outcome Measures

Primary Outcomes (1)

• POST H PYLORI TREATMENT RESULTS

  The primary end point was post-treatment result after triple or quadruple therapy

  2 months

Study Arms (2)

ARM A

EXPERIMENTAL

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

ARM B

EXPERIMENTAL

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

Interventions

ARM A Triple therapy for helicobacter pylori 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 A

ARM B Quadruple therapy for helicobacter pylori 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.

ARM B

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University Hospital

Karachi, Sindh, Pakistan

Location

Study Officials

• MUHAMMAD ASIM, MBBS

  ZIAUDDIN UNIVERSITY HOSPITAL

  PRINCIPAL INVESTIGATOR

• KHURRAM BAQAI, FCPS

  Ziauddin University

  PRINCIPAL INVESTIGATOR

• ZAIGHAM ABBAS, FCPS

  Ziauddin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GI FELLOW

Model Details: PARALLEL ASSIGNMENT

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: June 1, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)