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出境医 / 临床实验 / Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii

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

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Saccharomyces boulardii Drug: Placebo Phase 4

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: S.boulardi
Quadruple eradication therapy with S. boulardi
 Drug: Saccharomyces boulardii
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
Other Names:
  • Rabeprazole
  • Amoxicillin
  • Clarithromycin
  • Metronidazole
Placebo Comparator: Placebo
Quadruple eradication therapy without S. boulardi
 Drug: Placebo
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
Other Names:
  • Rabeprazole
  • Amoxicillin
  • Clarithromycin
  • Metronidazole
Outcome Measures
Primary Outcome Measures :
  1. Result of urea breath test (Eradication of H.pylori) [ Time Frame: 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 :
  1. Side effects of eradication therapy [ Time Frame: baseline to 8 weeks after the introduction of the therapy ]
    Number and severity of adverse events of standard eradication therapy

  2. Compliance of eradication therapy [ Time Frame: baseline to 8 weeks after the introduction of the therapy ]
    Patient successfully completed prescribed therapy


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Miodrag Krstic, MD, PhD +381113615575 krstic.miodrag61@gmail.com

Sponsors and Collaborators
Clinical Centre of Serbia
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date June 25, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019) 		Result of urea breath test (Eradication of H.pylori) [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Side effects of eradication therapy [ Time Frame: baseline to 8 weeks after the introduction of the therapy ]
    Number and severity of adverse events of standard eradication therapy
  • Compliance of eradication therapy [ Time Frame: baseline to 8 weeks after the introduction of the therapy ]
    Patient successfully completed prescribed therapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • Drug: Saccharomyces boulardii
    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
    Other Names:
    • Rabeprazole
    • Amoxicillin
    • Clarithromycin
    • Metronidazole
  • Drug: Placebo
    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
    Other Names:
    • Rabeprazole
    • Amoxicillin
    • Clarithromycin
    • Metronidazole
Study Arms  ICMJE
  • Experimental: S.boulardi
    Quadruple eradication therapy with S. boulardi
    Intervention: Drug: Saccharomyces boulardii
  • Placebo Comparator: Placebo
    Quadruple eradication therapy without S. boulardi
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997279
Other Study ID Numbers  ICMJE AB-2019-4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Miodrag Krstic, Clinical Centre of Serbia
Study Sponsor  ICMJE Clinical Centre of Serbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Clinical Centre of Serbia
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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