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Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

NCT02732249 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-06-26

No results posted yet for this study

Summary

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Esomeprazole

Given 30 min before morning and evening meals

DRUG

Bismuth Potassium Citrate

Given 30 min before morning and evening meals

DRUG

Clarithromycin

Given 30 min after morning and evening meals

DRUG

Metronidazole

Given 30 min after meals or at bedtime

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Hong lu, MD · Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02732249 on ClinicalTrials.gov