Probiotics to Promote Intestinal Health

Study Overview
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Brief Summary
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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 broad spectrum antimicrobials.

Official Title
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Randomized Controlled Trial of Lactobacillus Rhamnosus GG to Promote Intestinal Health

Conditions
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Communicable Diseases, Infection, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years old Admission to the non-ICU medical and surgical wards On broad spectrum antimicrobials with an anticipated length of stay of >48 hours Exclusion Criteria: Pregnancy Non English speaking Expected to die within 7 days Unable or unwilling to consent HIV infection with a CD4 count <200 Neutropenia with an absolute neutrophil count less than 500 cells/ml (or expected to drop to less than 500) Clinically significant diarrhea or history of C. difficile infection in the last 3 months History of VRE colonization and/or infection in the last year Transplant recipients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis | Dietary Supplement: Probiotic<br>* 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis<br>* Other names: Culturelle;|
| Placebo Comparator: Sugar Pill<br>Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis | Other: Placebo<br>* Sugar pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Acquisition of Any New Antibiotic-resistant Organism | Acquisition in the gastrointestinal tract of any new antibiotic resistant organism post-enrollment. Antibiotic resistant organisms include: C. difficile, vancomycin-resistant enterococci (VRE), multidrug-resistant Acinetobacter baumannii, multidrug-resistant Pseudomonas, ciprofloxacin-resistant Enterobacteriaceae, extended-spectrum betalactamase (ESBL) producing Enterobacteriaceae. | Outcome will be measured approximately every 3 days after enrollment throughout hospitalization, and at the time of discharge (the median duration of hospitalization was 13.5 days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics