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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diarrhea Death Pneumonia Drug: Lactobacillus casei variety rhamnosus granules Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial
Study Start Date : November 2010
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Kadit B
Probiotic Lactobacillus casei variety rhamnosus granules
 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
Placebo Comparator: Kadit A
Placebo
 Drug: Placebo

Placebo granules

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 28day-mortality [ Time Frame: 28 day ]
    Mortality in 28th day of ICU residence

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792739


Contacts
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Contact: Chang-Hoon Lee, Doctor 82 10 9563 2310 kauri670@gmail.com
Contact: Joo-Won Min, M.S 82 10 3321 7199 kmfindie@hanmail.net

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Bundang-Gu, Korea, Republic of, 463-707
Contact: Jong Sun Park, M.S    82 10 3297 4632    jspark.im@gmail.com   
Myongji Hospital Recruiting
Goyang, Deokyang-gu, Korea, Republic of, 412-270
Contact: Joo-Won Min, M.S    82-31-810-5423    kmfindie@hanmail.net   
SMG-SNU Boramae Medical Center Recruiting
Seoul, Dongjak-gu, Korea, Republic of, 156-707
Contact: Chang Hoon Lee, Doctor    82-10-9563-2310    kauri670@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chang Hoon Lee, Doctor Seoul National University College of Medicine
More Information
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Publications of Results:

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Responsible Party: Chang-Hoon Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01792739    
Other Study ID Numbers: ICU_probiotics
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Chang-Hoon Lee, Seoul National University Hospital:
Probiotics
Diarrhea
Intentive care units
Additional relevant MeSH terms:
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Pneumonia
Diarrhea
Lung Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive