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
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
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
NCT ID
NCT03368105
First Posted
December 4, 2017
Last Updated
December 8, 2017
Sponsor
Medical University of Silesia
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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