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Lactobacillus Preparation on the Incidence of Diarrhea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Chang-Hoon Lee, Seoul National University Hospital Identifier:
First received: February 9, 2012
Last updated: February 13, 2013
Last verified: February 2013

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 Intervention Phase
Drug: Lactobacillus casei variety rhamnosus granules
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 124
Study Start Date: November 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Placebo Comparator: Kadit A
Drug: Placebo

Placebo granules

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


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01792739

Contact: Chang-Hoon Lee, Doctor 82 10 9563 2310
Contact: Joo-Won Min, M.S 82 10 3321 7199

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   
Myongji Hospital Recruiting
Goyang, Deokyang-gu, Korea, Republic of, 412-270
Contact: Joo-Won Min, M.S    82-31-810-5423   
SMG-SNU Boramae Medical Center Recruiting
Seoul, Dongjak-gu, Korea, Republic of, 156-707
Contact: Chang Hoon Lee, Doctor    82-10-9563-2310   
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Chang Hoon Lee, Doctor Seoul National University College of Medicine
  More Information

Responsible Party: Chang-Hoon Lee, Assistant Professor, Seoul National University Hospital Identifier: NCT01792739     History of Changes
Other Study ID Numbers: ICU_probiotics
Study First Received: February 9, 2012
Last Updated: February 13, 2013

Keywords provided by Seoul National University Hospital:
Intentive care units

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on May 25, 2017