Lactobacillus Preparation on the Incidence of Diarrhea

Study Overview
=================
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.

Official Title
-----------------
The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial

Conditions
-----------------
Diarrhea, Death, Pneumonia

Intervention / Treatment
-----------------
* Drug: Lactobacillus casei variety rhamnosus granules
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kadit B<br>Probiotic Lactobacillus casei variety rhamnosus granules | Drug: Lactobacillus casei variety rhamnosus granules<br>* Lactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day)<br>* Other names: RAMNOS GRANULS;|
| Placebo Comparator: Kadit A<br>Placebo | Drug: Placebo<br>* Placebo granules : 3 gram per day (1g-1g-1g, 3 times per day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | The first onset of diarrhea during ICU residence (up to 8 weeks) | 
| ICU-acquired pneumonia | Definition of ICU-acquired pneumonia Newly developed pneumonia during ICU residence Aggravation of pneumonia during ICU residence | The first day of occurence of ICU-acquired pneumonia (up to 8 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Diarrhea, Intentive care units