Suspended

The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial

What is being tested

Lactobacillus casei variety rhamnosus granules

+ Placebo

Drug

Who is being recruted

Infections+8

+ Lung Diseases

+ Pathologic Processes

Over 20 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-ControlledPhase 4

Interventional

Study Start: November 2010

See protocol details

Summary

Principal SponsorSeoul National University Hospital

Study ContactChang-Hoon Lee, DoctorMore contacts

Last updated: February 15, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01792739

Principal SponsorSeoul National University Hospital

Study ContactChang-Hoon Lee, DoctorMore contacts

Last updated: February 15, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsLung DiseasesPathologic ProcessesRespiratory Tract DiseasesRespiratory Tract InfectionsSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsDeathDiarrheaPneumonia

Criteria

2 inclusion criteria required to participate

Age more than 19

All patients admitted in intensive care unit

5 exclusion criteria prevent from participating

Diarrhea occurence within 1 week of ICU admission

GI obstruction

History of abnormal symptoms and sign for the probiotics use (rash, edema, sepsis, etc.)

Recent history of probiotics use (within 1 month)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Probiotic Lactobacillus casei variety rhamnosus granules

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Seoul National University Bundang Hospital

Seongnam, South KoreaOpen Seoul National University Bundang Hospital in Google Maps

Recruiting

Myongji Hospital

Goyang, South Korea

Recruiting

SMG-SNU Boramae Medical Center

Seoul, South Korea

Suspended3 Study Centers