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Sequential Therapy Versus Quadruple Therapy in H. Pylori Eradication

NCT03156855 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2017-05-17

No results posted yet for this study

Summary

The investigators aimed to

1. compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment
2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
3. assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
4. assess the impact of eradication therapy on the metabolic factors

Conditions

  • Helicobacter

Interventions

DRUG

14-day sequential therapy

D1-D7: (esomeprazole 40mg qid + amoxicillin 500mg qid) for 7 days D8-D14: (esomeprazole 40mg qid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days

DRUG

Bismuth quadruple therapy

D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Sponsors & Collaborators

  • E-DA Hospital

    collaborator OTHER

  • National Taiwan University Hospital Hsin-Chu Branch

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Kaohsiung Medical University

    collaborator OTHER

  • Chiayi Christian Hospital

    collaborator OTHER

  • Mackay Memorial Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Ming-Shiang Wu, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Taiwan

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 NCT03156855 on ClinicalTrials.gov