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Completed

NCT Number: NCT03688828

Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori

The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therap.

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Key information

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Several studies previously suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events with PPI-based triple therapy. But, their effect for eradication of Hp is not yet conclusive. And the experiments now available about efficacy of Saccharomyces Boulardii were mainly combined with triple therapy. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Helicobacter pylori infected patients
  • 13C DOB>8
  • age 22~65

Exclusion criteria

  • prior Hp eradication therapy including amoxicillin and clarithromycin
  • previous gastric resection
  • allergic to the drugs used in this study
  • previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
  • Patients who were pregnant or lactating
  • Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy,diabete mellitus, hypertension…) effect the evaluation of this study
  • Can't express the complaint correctly

Treatment and study plan

Saccharomyces boulardii

Drug

500mg bid

Other names: Brad's yeast powder;Biocodex, Paris, France

Esomeprazole

Drug

20mg bid

Amoxicillin

Drug

1.0g bid

Clarithromycin

Drug

0.5g bid

Bismuth Potassium Citrate

Drug

0.22g bid

Primary outcomes

  1. Helicobacter pylori eradication

    Time frame: 6 weeks after treatment initiation

    to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 2 weeks and 4-12 weeks after treatment initiation

    to investigate the efficacy of Saccharomyces Boulardii sachets for reduction of incidence of adverse events

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • Anlu Puai Hospital
  • Central Hospital of Xiaogan
  • Hubei Aerospace Hospital
  • The Third People's Hospital of Hubei Province
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan University
  • Xiaogan First People's Hospital

Registry information

Official study title

The Evaluation of Saccharomyces Boulardii Sachets Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori: a Prospective, Multi-Center Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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