Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
89 participants
INTERVENTIONAL
2014-01-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Probiotic
Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Probiotic
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Sugar Pill
Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis
Placebo
Sugar pill
Interventions
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Probiotic
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Placebo
Sugar pill
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admission to the non-ICU medical and surgical wards
* On broad spectrum antimicrobials with an anticipated length of stay of \>48 hours
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
Washington University School of Medicine
OTHER
Responsible Party
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Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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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/
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.
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.
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.
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.
Centers for Disease Control and Prevention (CDC). Vital signs: carbapenem-resistant Enterobacteriaceae. MMWR Morb Mortal Wkly Rep. 2013 Mar 8;62(9):165-70.
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.
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.
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.
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.
Other Identifiers
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CK000162-aim3
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
201310102
Identifier Type: -
Identifier Source: org_study_id
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