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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kadit B | Experimental | Probiotic Lactobacillus casei variety rhamnosus granules |
|
| Kadit A | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus casei variety rhamnosus granules | Drug | Lactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 28day-mortality | Mortality in 28th day of ICU residence | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang-Hoon Lee, Doctor | Contact | 82 10 9563 2310 | kauri670@gmail.com | |
| Joo-Won Min, M.S | Contact | 82 10 3321 7199 | kmfindie@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Chang Hoon Lee, Doctor | Seoul National University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | Bundang-Gu | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17604300 | Result | 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. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D003643 | Death |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Placebo | Drug | Placebo granules : 3 gram per day (1g-1g-1g, 3 times per day) |
|
| The first onset of diarrhea during ICU residence (up to 8 weeks) |
| ICU-acquired pneumonia | Definition of ICU-acquired pneumonia
| The first day of occurence of ICU-acquired pneumonia (up to 8 weeks) |
| Myongji Hospital | Recruiting | Goyang | Deokyang-gu | 412-270 | South Korea |
|
| SMG-SNU Boramae Medical Center | Recruiting | Seoul | Dongjak-gu | 156-707 | South Korea |
|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |