The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

Phase 4

Completed

• Conditions: Infectious Disease of Digestive Tract
• Interventions: Dietary Supplement: Lactobacillus rhamnosus GG

• Registration Number: NCT01551186
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in patients on a ventilator.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2018-04-05
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-14
• Last Update Submitted: 2018-12-14
• Results First Posted: 2018-12-17
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Adults ≥ 18 years old
• Admission to the Medical ICU
• Expected to be on Mechanical Ventilation through an endotracheal tube for >48 hours

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Exclusion Criteria

• Pregnancy
• Immunosuppression
• Prosthetic valve or vascular graft
• Cardiac trauma
• Pancreatitis
• History of rheumatic fever
• Endocarditis or congenital cardiac abnormality
• Gastroesophageal or intestinal injury or foregut surgery during the current admission
• Oropharyngeal mucosal injury
• Placement of a tracheostomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Lactobacillus rhamnosus GG	Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis

Primary Outcome Measures

Name	Time	Method
Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE	Participants will be followed while Intubated, an expected average of 7 days. The outcome will be measured 3 days after enrollment and at the end of intubation, average time 7 days)	Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci, multidrug-resistant Acinetobacter baumannii, and multidrug- resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States