The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- Diarrhea-free days
研究概览
简要总结
The purpose of this trial is to clarify the impact of lactobacillus preparation on the incidence of diarrhea in ICU-admitted patients.
Almost all patients in ICU are treated with antibiotics for the effective control of various infections. However, antibiotics-associated diarrhea is another matter of concern. Many previous studies were proved that the use of probiotic lactobacillus preparation can reduce antibiotics-associated diarrhea in ward-admitted patients. In this study, we are planning to perform a similar study in severely ill patients in ICU.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted in intensive care unit
- •Age more than 19
排除标准
- •Diarrhea occurence within 1 week of ICU admission
- •Recent history of probiotics use (within 1 month)
- •GI obstruction
- •History of abnormal symptoms and sign for the probiotics use (rash, edema, sepsis, etc.)
- •immunocompromized patients
研究组 & 干预措施
Kadit A
Placebo
干预措施: Placebo (Drug)
Kadit B
Probiotic Lactobacillus casei variety rhamnosus granules
干预措施: Lactobacillus casei variety rhamnosus granules (Drug)
结局指标
主要结局
Diarrhea-free days
时间窗: Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)
If patients admit to ICU, the patient can be registered to probiotics or placebo arm. After the registration, probiotics would be administered to the patients. If loose stool \>600ml/day occurs during ICU residence, we can determine that occurence of diarrhea. "Diarrhea-free days" mean the duration from the day of 1st administration of probiotics till the day of 1st diarrhea. If patients are transferred to ward, this study ends in each patient.
次要结局
- 28day-mortality(28 day)
- Positive results of C.difficile toxin(The first onset of diarrhea during ICU residence (up to 8 weeks))
- ICU-acquired pneumonia(The first day of occurence of ICU-acquired pneumonia (up to 8 weeks))
研究者
Chang-Hoon Lee
Assistant Professor
Seoul National University Hospital