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Trial record 6 of 116 for:    Open Studies | "Diarrhea"
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Lactobacillus Preparation on the Incidence of Diarrhea

This study is currently recruiting participants.
Verified February 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Chang-Hoon Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01792739
First received: February 9, 2012
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Diarrhea
Death
Pneumonia
 Drug: Lactobacillus casei variety rhamnosus granules
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Diarrhea Pneumonia
U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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)

Other Name: RAMNOS GRANULS
Placebo Comparator: Kadit A
Placebo
 Drug: Placebo

Placebo granules

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

Other Name: Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792739

Contacts
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
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
Principal Investigator: Chang Hoon Lee, Doctor Seoul National University, College of Medicine
  More Information

Publications:

Responsible Party: Chang-Hoon Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01792739     History of Changes
Other Study ID Numbers: ICU_probiotics
Study First Received: February 9, 2012
Last Updated: February 13, 2013
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Probiotics
Diarrhea
Intentive care units

Additional relevant MeSH terms:
Diarrhea
Pneumonia
Signs and Symptoms, Digestive
Signs and Symptoms
 Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 19, 2013