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Probiotics to Promote Intestinal Health

Primary Purpose

Communicable Diseases, Infection, Anti-Infective Agents

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Communicable Diseases focused on measuring Probiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Sugar Pill

Arm Description

Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis

Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2014
Last Updated
March 29, 2022
Sponsor
Washington University School of Medicine
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT02046512
Brief Title
Probiotics to Promote Intestinal Health
Official Title
Randomized Controlled Trial of Lactobacillus Rhamnosus GG to Promote Intestinal Health
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communicable Diseases, Infection, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions
Keywords
Probiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Culturelle
Intervention Description
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sugar pill
Primary Outcome Measure Information:
Title
Number of Participants With Acquisition of Any New Antibiotic-resistant Organism
Description
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22574332
Citation
Lucado J, Gould C, Elixhauser A. Clostridium Difficile Infections (CDI) in Hospital Stays, 2009. 2012 Jan. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #124. Available from http://www.ncbi.nlm.nih.gov/books/NBK92613/
Results Reference
background
PubMed Identifier
22491338
Citation
Hall AJ, Curns AT, McDonald LC, Parashar UD, Lopman BA. The roles of Clostridium difficile and norovirus among gastroenteritis-associated deaths in the United States, 1999-2007. Clin Infect Dis. 2012 Jul;55(2):216-23. doi: 10.1093/cid/cis386. Epub 2012 Apr 4.
Results Reference
background
PubMed Identifier
21685488
Citation
Yahav D, Lador A, Paul M, Leibovici L. Efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother. 2011 Sep;66(9):1963-71. doi: 10.1093/jac/dkr242. Epub 2011 Jun 18.
Results Reference
background
PubMed Identifier
21288849
Citation
Kelesidis T, Humphries R, Uslan DZ, Pegues DA. Daptomycin nonsusceptible enterococci: an emerging challenge for clinicians. Clin Infect Dis. 2011 Jan 15;52(2):228-34. doi: 10.1093/cid/ciq113.
Results Reference
background
PubMed Identifier
21474585
Citation
Infectious Diseases Society of America (IDSA); Spellberg B, Blaser M, Guidos RJ, Boucher HW, Bradley JS, Eisenstein BI, Gerding D, Lynfield R, Reller LB, Rex J, Schwartz D, Septimus E, Tenover FC, Gilbert DN. Combating antimicrobial resistance: policy recommendations to save lives. Clin Infect Dis. 2011 May;52 Suppl 5(Suppl 5):S397-428. doi: 10.1093/cid/cir153. No abstract available.
Results Reference
background
PubMed Identifier
23466435
Citation
Centers for Disease Control and Prevention (CDC). Vital signs: carbapenem-resistant Enterobacteriaceae. MMWR Morb Mortal Wkly Rep. 2013 Mar 8;62(9):165-70.
Results Reference
background
PubMed Identifier
20522788
Citation
Morrow LE, Kollef MH, Casale TB. Probiotic prophylaxis of ventilator-associated pneumonia: a blinded, randomized, controlled trial. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1058-64. doi: 10.1164/rccm.200912-1853OC. Epub 2010 Jun 3.
Results Reference
background
PubMed Identifier
23728658
Citation
Goldenberg JZ, Ma SS, Saxton JD, Martzen MR, Vandvik PO, Thorlund K, Guyatt GH, Johnston BC. Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children. Cochrane Database Syst Rev. 2013 May 31;(5):CD006095. doi: 10.1002/14651858.CD006095.pub3.
Results Reference
background
PubMed Identifier
23362517
Citation
Johnston BC, Ma SS, Goldenberg JZ, Thorlund K, Vandvik PO, Loeb M, Guyatt GH. Probiotics for the prevention of Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Ann Intern Med. 2012 Dec 18;157(12):878-88. doi: 10.7326/0003-4819-157-12-201212180-00563.
Results Reference
background
PubMed Identifier
23247066
Citation
Hink T, Burnham CA, Dubberke ER. A systematic evaluation of methods to optimize culture-based recovery of Clostridium difficile from stool specimens. Anaerobe. 2013 Feb;19:39-43. doi: 10.1016/j.anaerobe.2012.12.001. Epub 2012 Dec 13.
Results Reference
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Probiotics to Promote Intestinal Health

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