A Phase 4 interventional study of Lactobacillus casei variety rhamnosus granules and Placebo in Diarrhea, Death and Pneumonia, sponsored by Seoul National University Hospital. Status unknown at 3 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Prevention
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.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's planned enrollment of 124 is close to the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Probiotic Lactobacillus casei variety rhamnosus granules
Drug: Lactobacillus casei variety rhamnosus granules
Placebo
Drug: Placebo
Lactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day)
Also known as: RAMNOS GRANULS
Placebo granules : 3 gram per day (1g-1g-1g, 3 times per day)
Diarrhea-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)
This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seoul National University Hospital