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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Saccharomyces boulardii
* Drug: Esomeprazole
* Drug: Amoxicillin
* Drug: Clarithromycin
* Drug: Bismuth potassium citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate | Drug: Saccharomyces boulardii<br>* 500mg bid<br>* Other names: Brad's yeast powder;Biocodex, Paris, France;Drug: Esomeprazole<br>* 20mg bid<br>Drug: Amoxicillin<br>* 1.0g bid<br>Drug: Clarithromycin<br>* 0.5g bid<br>Drug: Bismuth potassium citrate<br>* 0.22g bid<br>|
| Active Comparator: Quadruple Therapy<br>Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate | Drug: Esomeprazole<br>* 20mg bid<br>Drug: Amoxicillin<br>* 1.0g bid<br>Drug: Clarithromycin<br>* 0.5g bid<br>Drug: Bismuth potassium citrate<br>* 0.22g bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication | to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy. | 6 weeks after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | to investigate the efficacy of Saccharomyces Boulardii sachets for reduction of incidence of adverse events | 2 weeks and 4-12 weeks after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Saccharomyces Boulardii, Standard Quadruple Therapy