Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

Clostridium Difficile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03368105
• Other study ID #: SilesianMUKB-647/2017
• Status: Not yet recruiting
• Phase: N/A
• First received: December 4, 2017
• Last updated: December 8, 2017
• Start date: January 1, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2017
• Source: Medical University of Silesia
• Contact: Sylwia Dudzicz, MD
• Phone: 606305029
• Email: sylwia.dudzicz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile
• Infection

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clostridium difficile infection		During hospitalization - average of 14 days