Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clostridium difficile infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years old
- •organ transplantation or receiving immunosuppressive drugs for any other reasons
- •antibiotics therapy
排除标准
- •no consent to participate in the study
研究组 & 干预措施
LP299v group
Participants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy.
干预措施: Prevention of C. difficile infections using LP299v strain LP299v (Dietary Supplement)
Placebo group
Participants: one capsule of placebo orally per a day during the entire period of antibiotic therapy.
干预措施: Prevention of C. difficile infections using LP299v strain Placebo (Dietary Supplement)
结局指标
主要结局
Clostridium difficile infection
时间窗: Three month
次要结局
未报告次要终点
