Probiotics to Promote Intestinal Health

Phase 4CompletedNCT02046512

Washington University School of Medicine89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Communicable Diseases Infection Anti-Infective Agents Therapeutic Uses Pharmacologic Actions

Interventions

ProbioticDIETARY_SUPPLEMENT

1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis

PlaceboOTHER

Sugar pill

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Data from ClinicalTrials.gov

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