Diarrhea | Lactobacillus Preparation on the Incidence of Diarrhea
Diarrhea research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Lactobacillus casei variety rhamnosus granulesLactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day)
Drug:PlaceboPlacebo granules : 3 gram per day (1g-1g-1g, 3 times per day)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Kadit BProbiotic Lactobacillus casei variety rhamnosus granules
Start Date: November 2010
Completed Date: October 2013
Phase: Phase 4
Primary Outcome: Diarrhea-free days
Secondary Outcome: 28day-mortality
Study sponsors, principal investigator, and references
Principal Investigator: Chang Hoon Lee, Doctor
Lead Sponsor: Seoul National University Hospital
Hickson M, D'Souza AL, Muthu N, Rogers TR, Want S, Rajkumar C, Bulpitt CJ. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. BMJ. 2007 Jul 14;335(7610):80. Epub 2007 Jun 29.