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The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial
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.
Details
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 124 |
| Start date | 2010-11 |
| Completion | 2013-10 |
Conditions
- Diarrhea
- Death
- Pneumonia
Interventions
- Lactobacillus casei variety rhamnosus granules
- Placebo
Primary outcomes
- Diarrhea-free days — 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.
Countries
South Korea