Lactobacillus Preparation on the Incidence of Diarrhea

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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumonia; Diarrhea; Death
• Intervention / Treatment: Drug: Lactobacillus casei variety rhamnosus granules; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-Gu
    • Seongnam, Bundang-Gu, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Jong Sun Park, M.S; Phone Number: 82 10 3297 4632; Email: jspark.im@gmail.com
  • Deokyang-gu
    • Goyang, Deokyang-gu, Korea, Republic of, 412-270
      • Recruiting
      • Myongji Hospital
      • Contact: Joo-Won Min, M.S; Phone Number: 82-31-810-5423; Email: kmfindie@hanmail.net
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of, 156-707
      • Recruiting
      • SMG-SNU Boramae Medical Center
      • Contact: Chang Hoon Lee, Doctor; Phone Number: 82-10-9563-2310; Email: kauri670@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: RAMNOS GRANULS
Placebo Comparator: Kadit A; Placebo	Drug: Placebo; Placebo granules : 3 gram per day (1g-1g-1g, 3 times per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
28day-mortality	Mortality in 28th day of ICU residence	28 day
Positive results of C.difficile toxin	If diarrhea (>600ml/day) occurs during ICU residence, we will perform C.difficile toxin assays to determine the cause of diarrhea.	The first onset of diarrhea during ICU residence (up to 8 weeks)
ICU-acquired pneumonia	Definition of ICU-acquired pneumonia; Newly developed pneumonia during ICU residence; Aggravation of pneumonia during ICU residence	The first day of occurence of ICU-acquired pneumonia (up to 8 weeks)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chang Hoon Lee, Doctor, Seoul National University College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Diarrhea; Probiotics; Intentive care units
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: ICU_probiotics

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No