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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03368105

Enrollment

300

Registered

2017-12-11

Start date

2018-01-01

Completion date

2021-07-01

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile

Keywords

Clostridium difficile Infection, Lactobacillus plantarum 299v, organ transplantation, antibiotic-associated diarrhoea

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.

Interventions

DIETARY_SUPPLEMENTPrevention 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Contacts

Primary ContactSylwia Dudzicz, MD

sylwia.dudzicz@gmail.com606305029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026