An interventional study of Prevention of C. difficile infections using LP299v strain Placebo and Prevention of C. difficile infections using LP299v strain LP299v in Clostridioides Difficile Infection, sponsored by Medical University of Silesia. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Medical University of Silesia · Not applicable, Interventional, and Prevention
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.
The study is prospective. It will include 300 patients undergoing antibiotic therapy. The duration of the study is estimated at 36 months (from 01.10.2024 to 31.10.2027).
The study will be conducted among patients hospitalized in the Clinic of Nephrology, Transplantology and Internal Medicine of the Medical University of Silesia/Department of Nephrology, Transplantology and Internal Medicine of the Independent Public Clinical Hospital named after Andrzej Mielęcki of the Medical University of Silesia in Katowice. The study will include patients undergoing immunosuppressive treatment undergoing antibiotic therapy. The exclusion criterion from the study is the lack of consent of the patient to participate in the study.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.
The patient interview will include, among others:
The following laboratory and microbiological tests are planned for all patients in the randomized study:
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 300 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Medical University of Silesia is the lead sponsor of 111 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Participants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy.
Dietary Supplement: Prevention of C. difficile infections using LP299v strain LP299v
Participants: one capsule of placebo orally per a day during the entire period of antibiotic therapy.
Dietary Supplement: 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.
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.
Clostridium difficile infection
Time frame: Three month
Plan to share: Undecided
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Medical University of Silesia