Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii

Study Overview
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Brief Summary
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This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.

Detailed Description
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Standard triple therapy for H. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.Therefore, the latest Maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. The addition of probiotics with eradication therapy has never become a standard treatment. However, the Maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy. The study was designed as a prospective, double-blind, randomized, case-control intervention study.

Official Title
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Double-blind, Placebo-controlled, Randomized Study for Assesment of the Efficiency and Safety Quadruple Therapy for Helicobacter Pylori Infection With or Without the Addition of Saccharomyces Boulardi Probiotic

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Saccharomyces boulardii
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dyspepsia Patients not treated for H. Pylori Age of 18-50 years Positive urea breath test Exclusion Criteria: Alarm symptoms (anemia, persistent vomiting, hematemesis, dysphagia, significant weight loss, palpable mass in abdomen) Gastric cancer Immunosuppressive therapy Use of acetylsalicylic acid Severe renal failure Severe liver failure Immunodeficiency Proven malignant disease Penicillin allergy Allergy to any component of dietary supplement (Saccharomyces boulardii and Vitamin D) Chronic alcoholism Pregnancy Lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: S.boulardi<br>Quadruple eradication therapy with S. boulardi | Drug: Saccharomyces boulardii<br>* Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Saccharomyces boulardi 500 mg 1x1, for 3 week<br>* Other names: Metronidazole;|
| Placebo Comparator: Placebo<br>Quadruple eradication therapy without S. boulardi | Drug: Placebo<br>* Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Placebo 1x1, for 3 week<br>* Other names: Metronidazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of urea breath test (Eradication of H.pylori) | Test remains positive (Eradication of H.pylori unsuccessful) or test becomes negative (eradication of H.pylori successful) | baseline to 8 weeks after the introduction of the therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of eradication therapy | Number and severity of adverse events of standard eradication therapy | baseline to 8 weeks after the introduction of the therapy | 
| Compliance of eradication therapy | Patient successfully completed prescribed therapy | baseline to 8 weeks after the introduction of the therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter Pylori, Saccharomyces boulardi, Eradication therapy