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Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

Primary Purpose

Clostridium Difficile

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prevention of C. difficile infections using LP299v strain
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile focused on measuring Clostridium difficile Infection, Lactobacillus plantarum 299v, organ transplantation, antibiotic-associated diarrhoea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • over 18 years old
  • organ transplantation or receiving immunosuppressive drugs for any other reasons
  • antibiotics therapy

Exclusion Criteria:

  • no consent to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    LP299v group

    Placebo group

    Arm Description

    Participants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy.

    Participants: one capsule of placebo orally per a day during the entire period of antibiotic therapy.

    Outcomes

    Primary Outcome Measures

    Clostridium difficile infection

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2017
    Last Updated
    December 8, 2017
    Sponsor
    Medical University of Silesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03368105
    Brief Title
    Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain
    Official Title
    Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2018 (Anticipated)
    Primary Completion Date
    January 1, 2021 (Anticipated)
    Study Completion Date
    July 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Silesia

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward. Patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study. Participants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo.
    Detailed Description
    Clostridium difficile is currently the most frequently identified pathogen causing antibiotic-associated diarrhoea and the main cause of nosocomial diarrhoea. In regard to observed worldwide increase rate of infection and mortality from CDI the prevention of Clostridium difficile infections seems to be crucial, especially in patients at CDI high risk. So far, it has not been unambiguously proven that probiotics are effective in the prevention of Clostridium difficile infection among patients undergoing antibiotic therapy. The Lactobacillus plantarum 299v (LP299v) is a Gram-positive lactic acid bacteria that naturally occurs on the surface of human intestinal mucosa. Specific properties to the gut mucosa colonization are due to mannose-dependent adhesion of LP299v to the epithelium of human intestines.This ability of LP299v leads to reduction of bacterial translocation from the intestinal lumen into the blood vessels, can prevent adhesion of many pathogens to intestinal epithelium and modulate the inflammatory response of the epithelium. The strain 299v of Lactobacillus plantarum has been found to decrease the severity of gastrointestinal adverse effects during antibiotic therapy. Limited data are available regarding the efficacy of LP299v for preventing Clostridium difficile infections.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clostridium Difficile
    Keywords
    Clostridium difficile Infection, Lactobacillus plantarum 299v, organ transplantation, antibiotic-associated diarrhoea

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LP299v group
    Arm Type
    Experimental
    Arm Description
    Participants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Participants: one capsule of placebo orally per a day during the entire period of antibiotic therapy.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Prevention of C. difficile infections using LP299v strain
    Intervention Description
    Patients treated with antibiotics and at high CDI risk (patients after organ transplantation or receiving immunosuppressive therapy for any other reason) will be enroll to study. We will divide participants into two group. Group 1 will receive one capsule of LP299v orally per a day during the entire period of antibiotic therapy. Group 2 will receive one capsule of placebo during the entire period of antibiotic therapy.
    Primary Outcome Measure Information:
    Title
    Clostridium difficile infection
    Time Frame
    During hospitalization - average of 14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: over 18 years old organ transplantation or receiving immunosuppressive drugs for any other reasons antibiotics therapy Exclusion Criteria: no consent to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sylwia Dudzicz, MD
    Phone
    606305029
    Email
    sylwia.dudzicz@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

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