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Lactobacillus Preparation on the Incidence of Diarrhea

Primary Purpose

Diarrhea, Death, Pneumonia

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lactobacillus casei variety rhamnosus granules
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring Probiotics, Diarrhea, Intentive care units

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Myongji HospitalRecruiting
  • SMG-SNU Boramae Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Kadit B

Kadit A

Arm Description

Probiotic Lactobacillus casei variety rhamnosus granules

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

28day-mortality
Mortality in 28th day of ICU residence
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.
ICU-acquired pneumonia
Definition of ICU-acquired pneumonia Newly developed pneumonia during ICU residence Aggravation of pneumonia during ICU residence

Full Information

First Posted
February 9, 2012
Last Updated
February 13, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01792739
Brief Title
Lactobacillus Preparation on the Incidence of Diarrhea
Official Title
The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Death, Pneumonia
Keywords
Probiotics, Diarrhea, Intentive care units

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kadit B
Arm Type
Experimental
Arm Description
Probiotic Lactobacillus casei variety rhamnosus granules
Arm Title
Kadit A
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Lactobacillus casei variety rhamnosus granules
Other Intervention Name(s)
RAMNOS GRANULS
Intervention Description
Lactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo granules : 3 gram per day (1g-1g-1g, 3 times per day)
Primary Outcome Measure Information:
Title
Diarrhea-free days
Description
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.
Time Frame
Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)
Secondary Outcome Measure Information:
Title
28day-mortality
Description
Mortality in 28th day of ICU residence
Time Frame
28 day
Title
Positive results of C.difficile toxin
Description
If diarrhea (>600ml/day) occurs during ICU residence, we will perform C.difficile toxin assays to determine the cause of diarrhea.
Time Frame
The first onset of diarrhea during ICU residence (up to 8 weeks)
Title
ICU-acquired pneumonia
Description
Definition of ICU-acquired pneumonia Newly developed pneumonia during ICU residence Aggravation of pneumonia during ICU residence
Time Frame
The first day of occurence of ICU-acquired pneumonia (up to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-Hoon Lee, Doctor
Phone
82 10 9563 2310
Email
kauri670@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joo-Won Min, M.S
Phone
82 10 3321 7199
Email
kmfindie@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Hoon Lee, Doctor
Organizational Affiliation
Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Bundang-Gu
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Sun Park, M.S
Phone
82 10 3297 4632
Email
jspark.im@gmail.com
Facility Name
Myongji Hospital
City
Goyang
State/Province
Deokyang-gu
ZIP/Postal Code
412-270
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Won Min, M.S
Phone
82-31-810-5423
Email
kmfindie@hanmail.net
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
State/Province
Dongjak-gu
ZIP/Postal Code
156-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Hoon Lee, Doctor
Phone
82-10-9563-2310
Email
kauri670@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
17604300
Citation
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.
Results Reference
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Lactobacillus Preparation on the Incidence of Diarrhea

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