Study to Prevent Clostridium Difficile Infections Using Lactobacillus Plantarum 299v in Adults Receiving Antibiotics and Immunosuppressive Therapy in Nephrology and Transplantation

What this Trial Is About

This research aims to evaluate if using the Lactobacillus plantarum 299v LP299v strain can lower the risk of Clostridium difficile infection CDI in adults who are in a high-risk group. These patients are hospitalized in a nephrology and transplantation ward and are receiving immunosuppressive drugs along with antibiotic therapy. The study is prospective and planned to recruit 300 patients over a period from October 2024 to October 2027. Participants will be randomly assigned to one of two groups. One group will receive a daily oral capsule of the probiotic LP299v containing approximately 10 billion live bacteria, while the other group will receive a placebo capsule. Both treatments will be taken with a meal for three months during their antibiotic therapy. The study includes a three-month observation period to monitor the effects. During the study, participants will have interviews to assess gastrointestinal symptoms and infections. Physical examinations and laboratory tests will be conducted, including stool microbiology and blood markers like C-reactive protein and interleukin 6 at multiple time points. After the three-month treatment and observation, a telephone interview will collect further information on gastrointestinal health and infections. The main outcome measured will be the occurrence of Clostridium difficile infection within three months.

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