Death, Diarrhea, Pneumonia
Conditions
Keywords
Probiotics, Diarrhea, Intentive care units
Brief summary
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.
Interventions
DRUGPlacebo
Placebo granules : 3 gram per day (1g-1g-1g, 3 times per day)
DRUGLactobacillus casei variety rhamnosus granules
Lactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted in intensive care unit * Age more than 19
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28day-mortality | 28 day | Mortality in 28th day of ICU residence |
| Positive results of C.difficile toxin | The first onset of diarrhea during ICU residence (up to 8 weeks) | If diarrhea (\>600ml/day) occurs during ICU residence, we will perform C.difficile toxin assays to determine the cause of diarrhea. |
| ICU-acquired pneumonia | The first day of occurence of ICU-acquired pneumonia (up to 8 weeks) | Definition of ICU-acquired pneumonia 1. Newly developed pneumonia during ICU residence 2. Aggravation of pneumonia during ICU residence |
Countries
South Korea
Contacts
Primary ContactChang-Hoon Lee, Doctor
Backup ContactJoo-Won Min, M.S
Outcome results
None listed