NCT01792739

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2010

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

February 9, 2012

Last Update Submit

February 13, 2013

Conditions

DiarrheaDeathPneumonia

Keywords

ProbioticsDiarrheaIntentive care units

Outcome Measures

Primary Outcomes (1)

  • 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.

    Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)

Secondary Outcomes (3)

  • 28day-mortality

    28 day

  • Positive results of C.difficile toxin

    The first onset of diarrhea during ICU residence (up to 8 weeks)

  • ICU-acquired pneumonia

    The first day of occurence of ICU-acquired pneumonia (up to 8 weeks)

Study Arms (2)

Kadit B

EXPERIMENTAL

Probiotic Lactobacillus casei variety rhamnosus granules

Drug: Lactobacillus casei variety rhamnosus granules

Kadit A

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Lactobacillus casei variety rhamnosus granulesDRUG

Lactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day)

Also known as: RAMNOS GRANULS
Kadit B
PlaceboDRUG

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

Kadit A

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted in intensive care unit
  • Age more than 19

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam, Bundang-Gu, 463-707, South Korea

RECRUITING

Myongji Hospital

Goyang, Deokyang-gu, 412-270, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, Dongjak-gu, 156-707, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 17604300RESULT

MeSH Terms

Conditions

DiarrheaDeathPneumonia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chang Hoon Lee, Doctor

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang-Hoon Lee, Doctor

CONTACT

82 10 9563 2310kauri670@gmail.com

Joo-Won Min, M.S

CONTACT

82 10 3321 7199kmfindie@hanmail.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 15, 2013

Study Start

November 1, 2010

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

KR(3)