Lactobacillus Preparation on the Incidence of Diarrhea

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Death; Diarrhea; Pneumonia

Treatments: Drug: Placebo; Drug: Lactobacillus casei variety rhamnosus granules

Study type: Interventional

Funder types: Other

Identifiers

NCT01792739

ICU_probiotics

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups, including a placebo group

Kadit B

Experimental group

Description:

Probiotic Lactobacillus casei variety rhamnosus granules

Treatment:

Drug: Lactobacillus casei variety rhamnosus granules

Kadit A

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo