Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
124 participants
INTERVENTIONAL
2010-11-30
2013-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Kadit B
Probiotic Lactobacillus casei variety rhamnosus granules
Lactobacillus casei variety rhamnosus granules
Lactobacillus casei variety rhamnosus granules
: 3 gram per day (1g-1g-1g, 3 times per day)
Kadit A
Placebo
Placebo
Placebo granules
: 3 gram per day (1g-1g-1g, 3 times per day)
Interventions
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Lactobacillus casei variety rhamnosus granules
Lactobacillus casei variety rhamnosus granules
: 3 gram per day (1g-1g-1g, 3 times per day)
Placebo
Placebo granules
: 3 gram per day (1g-1g-1g, 3 times per day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age more than 19
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Chang-Hoon Lee
Assistant Professor
Principal Investigators
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Chang Hoon Lee, Doctor
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
Locations
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Seoul National University Bundang Hospital
Seongnam, Bundang-Gu, South Korea
Myongji Hospital
Goyang, Deokyang-gu, South Korea
SMG-SNU Boramae Medical Center
Seoul, Dongjak-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1136/bmj.39231.599815.55. Epub 2007 Jun 29.
Other Identifiers
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ICU_probiotics
Identifier Type: -
Identifier Source: org_study_id
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