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Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
Sponsor: Medical University of Silesia
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. Adutt patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study. Patients who meet the above criteria for inclusion in the study will be assigned to one of two groups. Patients in group I (study) will receive a probiotic containing the Lactobacillus plantarum 299v strain of bacteria as part of the prophylaxis of Clostridioides difficile infection. The daily dose is 1 capsule containing approximately 10x109 colony-forming units of live bacteria taken orally with a meal. Patients in group II (control) will receive a placebo. The duration of probiotic or placebo use will be 3 months. Assignment to groups I and II will be random. The number of patients in each group will be 150. 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. The observation period will last 3 months. The evaluation will consist of an interview, physical examination and laboratory tests.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-10-01
Completion Date
2027-10-31
Last Updated
2025-03-05
Healthy Volunteers
No
Conditions
Interventions
Prevention of C. difficile infections using LP299v strain Placebo
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. One capsule of placebo orally per a day during the entire period of antibiotic therapy.
Prevention of C. difficile infections using LP299v strain LP299v
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. One capsule of LP299v orally per a day during the entire period of antibiotic therapy.
Locations (1)
Department of Nephrology, Transplantation and Intenal Medicine Medical University of Silesia
Poland, Silesian Voivodeship, Poland