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Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

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ClinicalTrials.gov Identifier: NCT03368105
Recruitment Status : Not yet recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Medical University of Silesia

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.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Dietary Supplement: Prevention of C. difficile infections using LP299v strain Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LP299v group
Participants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy.
Dietary Supplement: Prevention of C. difficile infections using LP299v strain

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.


Placebo Comparator: Placebo group
Participants: one capsule of placebo orally per a day during the entire period of antibiotic therapy.
Dietary Supplement: Prevention of C. difficile infections using LP299v strain

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 Measures :
  1. Clostridium difficile infection [ Time Frame: During hospitalization - average of 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368105


Contacts
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Contact: Sylwia Dudzicz, MD 606305029 sylwia.dudzicz@gmail.com

Sponsors and Collaborators
Medical University of Silesia

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Responsible Party: Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03368105     History of Changes
Other Study ID Numbers: SilesianMUKB-647/2017
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Medical University of Silesia:
Clostridium difficile Infection
Lactobacillus plantarum 299v
organ transplantation
antibiotic-associated diarrhoea

Additional relevant MeSH terms:
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Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents