Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

Medical University of Silesia

Status: Unknown

Conditions: Clostridium Difficile

Treatments: Dietary Supplement: Prevention of C. difficile infections using LP299v strain

Study type: Interventional

Funder types: Other

Identifiers

NCT03368105

SilesianMUKB-647/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

LP299v group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Prevention of C. difficile infections using LP299v strain

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Prevention of C. difficile infections using LP299v strain