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

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT06859437
Lead Sponsor Medical University of Silesia
Conditions
(from sponsor)
Clostridioides Difficile Infection
Related terms Clostridium Infections
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov