Lactobacillus Preparation on the Incidence of Diarrhea

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01792739
• Other study ID #: ICU_probiotics
• Status: Recruiting
• Phase: Phase 4
• First received: February 9, 2012
• Last updated: February 13, 2013
• Start date: November 2010
• Est. completion date: October 2013

Study information

• Verified date: February 2013
• Source: Seoul National University Hospital
• Contact: Chang-Hoon Lee, Doctor
• Phone: 82 10 9563 2310
• Email: kauri670[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Death
• Diarrhea
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Myongji Hospital	Goyang	Deokyang-gu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Bundang-Gu
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul	Dongjak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	28day-mortality	Mortality in 28th day of ICU residence	28 day	No
Secondary	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)	No
Secondary	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)	No