Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department

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.

Study Overview

• Status: Unknown
• Conditions: Clostridium Difficile
• Intervention / Treatment: Dietary supplement: Prevention of C. difficile infections using LP299v strain

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylwia Dudzicz, MD; Phone Number: 606305029; Email: sylwia.dudzicz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clostridium difficile infection	During hospitalization - average of 14 days

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Clostridium difficile Infection; organ transplantation; Lactobacillus plantarum 299v; antibiotic-associated diarrhoea
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Clostridium Infections
• Other Study ID Numbers: SilesianMUKB-647/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No