Lactobacillus Preparation on the Incidence of Diarrhea

Phase 4

• Conditions: Diarrhea; Death; Pneumonia
• Interventions: Drug: Lactobacillus casei variety rhamnosus granules; Drug: Placebo

• Registration Number: NCT01792739
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-02-09
• Status Verified: 2013-02
• Study First Submitted QC: 2013-02-13
• Last Update Submitted: 2013-02-13
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• All patients admitted in intensive care unit
• Age more than 19

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kadit B	Lactobacillus casei variety rhamnosus granules	Probiotic Lactobacillus casei variety rhamnosus granules
Kadit A	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Diarrhea-free days	Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
28day-mortality	28 day	Mortality in 28th day of ICU residence
Positive results of C.difficile toxin	The first onset of diarrhea during ICU residence (up to 8 weeks)	If diarrhea (\>600ml/day) occurs during ICU residence, we will perform C.difficile toxin assays to determine the cause of diarrhea.
ICU-acquired pneumonia	The first day of occurence of ICU-acquired pneumonia (up to 8 weeks)	Definition of ICU-acquired pneumonia; 1. Newly developed pneumonia during ICU residence; 2. Aggravation of pneumonia during ICU residence

Trial Locations

Locations (3)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Bundang-Gu, Korea, Republic of

Myongji Hospital; 🇰🇷 Goyang, Deokyang-gu, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Dongjak-gu, Korea, Republic of