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

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Saccharomyces boulardii; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Bismuth potassium citrate

• Registration Number: NCT03688828
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Study Start: 2018-11-11
• Primary Completion: 2020-06-10
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-23
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Saccharomyces boulardii	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Probiotics	Amoxicillin	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Probiotics	Bismuth potassium citrate	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Quadruple Therapy	Bismuth potassium citrate	Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Probiotics	Esomeprazole	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Probiotics	Clarithromycin	Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Quadruple Therapy	Esomeprazole	Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Quadruple Therapy	Clarithromycin	Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Quadruple Therapy	Amoxicillin	Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication	6 weeks after treatment initiation	to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	2 weeks and 4-12 weeks after treatment initiation	to investigate the efficacy of Saccharomyces Boulardii sachets for reduction of incidence of adverse events

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China