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Lactobacillus Preparation for Diarrhea in ICU Patients
NCT01792739Phase 4
Key facts
- Status
- Unknown
- Start
- Nov 2010
- Primary completion
- Sep 2013
- Countries
- 1
- Sponsor
- Seoul National University Hospital
- Modality
- Live Biotherapeutic Products
- Conditions
- diarrhea
01
Overview
Phase 4, randomised trial of lactobacillus rhamnosus in diarrhea (2 arms), sponsored by Seoul National University Hospital. Primary endpoint: Diarrhea-free days at 8 weeks. Status: unknown.
02
Design
2 arms- Study design
- Randomized
Kadit B
Lactobacillus casei variety rhamnosus granules
Kadit A
Placebo granules
03
Who it enrols
Adult patients admitted to the ICU without recent diarrhea, recent probiotics use, GI obstruction, or immunocompromised status.
04
Endpoints
Primary
Diarrhea-free days
Secondary
28-day mortality
Positive results of C.difficile toxin
ICU-acquired pneumonia
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