Probiotics to Promote Intestinal Health

Phase 4

Completed

• Conditions: Pharmacologic Actions; Communicable Diseases; Infection; Therapeutic Uses; Anti-Infective Agents
• Interventions: Dietary Supplement: Probiotic; Other: Placebo

• Registration Number: NCT02046512
• 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 broad spectrum antimicrobials.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Primary Completion: 2015-10
• Study Completion: 2018-12
• Results First Submitted: 2022-01-26
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Results First Posted: 2022-04-04
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Sugar Pill	Placebo	Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acquisition of Any New Antibiotic-resistant Organism	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).	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.

Trial Locations

Locations (1)

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