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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
124
Lactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day)
Placebo granules : 3 gram per day (1g-1g-1g, 3 times per day)
Seoul National University Bundang Hospital
Seongnam, Bundang-Gu, South Korea
RECRUITINGMyongji Hospital
Goyang, Deokyang-gu, South Korea
RECRUITINGSMG-SNU Boramae Medical Center
Seoul, Dongjak-gu, South Korea
RECRUITINGDiarrhea-free days
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.
Time frame: Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)
28day-mortality
Mortality in 28th day of ICU residence
Time frame: 28 day
Positive results of C.difficile toxin
If diarrhea (\>600ml/day) occurs during ICU residence, we will perform C.difficile toxin assays to determine the cause of diarrhea.
Time frame: The first onset of diarrhea during ICU residence (up to 8 weeks)
ICU-acquired pneumonia
Definition of ICU-acquired pneumonia 1. Newly developed pneumonia during ICU residence 2. Aggravation of pneumonia during ICU residence
Time frame: The first day of occurence of ICU-acquired pneumonia (up to 8 weeks)
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