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

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Placebo; Drug: Saccharomyces boulardii

• Registration Number: NCT03997279
• Lead Sponsor: Clinical Centre of Serbia

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Study First Posted: 2019-06-25
• Last Update Posted: 2019-06-25
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Quadruple eradication therapy without S. boulardi
S.boulardi	Saccharomyces boulardii	Quadruple eradication therapy with S. boulardi

Primary Outcome Measures

Name	Time	Method
Result of urea breath test (Eradication of H.pylori)	baseline to 8 weeks after the introduction of the therapy	Test remains positive (Eradication of H.pylori unsuccessful) or test becomes negative (eradication of H.pylori successful)

Secondary Outcome Measures

Name	Time	Method
Side effects of eradication therapy	baseline to 8 weeks after the introduction of the therapy	Number and severity of adverse events of standard eradication therapy
Compliance of eradication therapy	baseline to 8 weeks after the introduction of the therapy	Patient successfully completed prescribed therapy