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Lactobacillus Preparation on the Incidence of Diarrhea

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ClinicalTrials.gov Identifier: NCT01792739
Recruitment Status : Unknown
Verified February 2013 by Chang-Hoon Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Chang-Hoon Lee, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE February 15, 2013
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2013)
Diarrhea-free days [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2013)
  • 28day-mortality [ Time Frame: 28 day ]
    Mortality in 28th day of ICU residence
  • Positive results of C.difficile toxin [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lactobacillus Preparation on the Incidence of Diarrhea
Official Title  ICMJE The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Diarrhea
  • Death
  • Pneumonia
Intervention  ICMJE
  • Drug: Lactobacillus casei variety rhamnosus granules

    Lactobacillus casei variety rhamnosus granules

    : 3 gram per day (1g-1g-1g, 3 times per day)

    Other Name: RAMNOS GRANULS
  • Drug: Placebo

    Placebo granules

    : 3 gram per day (1g-1g-1g, 3 times per day)

Study Arms  ICMJE
  • Experimental: Kadit B
    Probiotic Lactobacillus casei variety rhamnosus granules
    Intervention: Drug: Lactobacillus casei variety rhamnosus granules
  • Placebo Comparator: Kadit A
    Placebo
    Intervention: Drug: Placebo
Publications * 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. Epub 2007 Jun 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 13, 2013)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01792739
Other Study ID Numbers  ICMJE ICU_probiotics
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang-Hoon Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chang Hoon Lee, Doctor Seoul National University College of Medicine
PRS Account Seoul National University Hospital
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP