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

Primary Purpose

Helicobacter Pylori Infection

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Saccharomyces boulardii
Placebo
Sponsored by
Clinical Centre of Serbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter Pylori, Saccharomyces boulardi, Eradication therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    S.boulardi

    Placebo

    Arm Description

    Quadruple eradication therapy with S. boulardi

    Quadruple eradication therapy without S. boulardi

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Side effects of eradication therapy
    Number and severity of adverse events of standard eradication therapy
    Compliance of eradication therapy
    Patient successfully completed prescribed therapy

    Full Information

    First Posted
    June 12, 2019
    Last Updated
    June 21, 2019
    Sponsor
    Clinical Centre of Serbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03997279
    Brief Title
    Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clinical Centre of Serbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Helicobacter Pylori Infection
    Keywords
    Helicobacter Pylori, Saccharomyces boulardi, Eradication therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    S.boulardi
    Arm Type
    Experimental
    Arm Description
    Quadruple eradication therapy with S. boulardi
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Quadruple eradication therapy without S. boulardi
    Intervention Type
    Drug
    Intervention Name(s)
    Saccharomyces boulardii
    Other Intervention Name(s)
    Rabeprazole, Amoxicillin, Clarithromycin, Metronidazole
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Rabeprazole, Amoxicillin, Clarithromycin, Metronidazole
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Result of urea breath test (Eradication of H.pylori)
    Description
    Test remains positive (Eradication of H.pylori unsuccessful) or test becomes negative (eradication of H.pylori successful)
    Time Frame
    baseline to 8 weeks after the introduction of the therapy
    Secondary Outcome Measure Information:
    Title
    Side effects of eradication therapy
    Description
    Number and severity of adverse events of standard eradication therapy
    Time Frame
    baseline to 8 weeks after the introduction of the therapy
    Title
    Compliance of eradication therapy
    Description
    Patient successfully completed prescribed therapy
    Time Frame
    baseline to 8 weeks after the introduction of the therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miodrag Krstic, MD, PhD
    Phone
    +381113615575
    Email
    krstic.miodrag61@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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