Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

Not Applicable

• Conditions: Clostridium Difficile
• Interventions: Dietary Supplement: Prevention of C. difficile infections using LP299v strain

• Registration Number: NCT03368105
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-08
• Last Update Submitted: 2017-12-08
• Study First Posted: 2017-12-11
• Last Update Posted: 2017-12-11
• Study Start: 2018-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clostridium difficile infection	During hospitalization - average of 14 days