Lactobacillus Preparation on the Incidence of Diarrhea

NCT ID: NCT01792739

Last Updated: 2013-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diarrhea Death Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Kadit B

Probiotic Lactobacillus casei variety rhamnosus granules

Group Type EXPERIMENTAL

Lactobacillus casei variety rhamnosus granules

Intervention Type DRUG

Lactobacillus casei variety rhamnosus granules

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

Kadit A

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo granules

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

Interventions

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Lactobacillus casei variety rhamnosus granules

Lactobacillus casei variety rhamnosus granules

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

Intervention Type DRUG

Placebo

Placebo granules

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

Intervention Type DRUG

Other Intervention Names

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RAMNOS GRANULS

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang-Hoon Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Hoon Lee, Doctor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine

Locations

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Seoul National University Bundang Hospital

Seongnam, Bundang-Gu, South Korea

Site Status RECRUITING

Myongji Hospital

Goyang, Deokyang-gu, South Korea

Site Status RECRUITING

SMG-SNU Boramae Medical Center

Seoul, Dongjak-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chang-Hoon Lee, Doctor

Role: CONTACT

82 10 9563 2310

Joo-Won Min, M.S

Role: CONTACT

82 10 3321 7199

Facility Contacts

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Jong Sun Park, M.S

Role: primary

82 10 3297 4632

Joo-Won Min, M.S

Role: primary

82-31-810-5423

Chang Hoon Lee, Doctor

Role: primary

82-10-9563-2310

References

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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.

Reference Type RESULT
PMID: 17604300 (View on PubMed)

Other Identifiers

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ICU_probiotics

Identifier Type: -

Identifier Source: org_study_id

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