The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria
NCT ID: NCT01551186
Last Updated: 2018-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2012-02-29
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Probiotic
Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis
Lactobacillus rhamnosus GG
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Standard of Care
Patients in the control arm will receive standard care
No interventions assigned to this group
Interventions
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Lactobacillus rhamnosus GG
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admission to the Medical ICU
* Expected to be on Mechanical Ventilation through an endotracheal tube for \>48 hours
Exclusion Criteria
* Immunosuppression
* Prosthetic valve or vascular graft
* Cardiac trauma
* Pancreatitis
* History of rheumatic fever
* Endocarditis or congenital cardiac abnormality
* Gastroesophageal or intestinal injury or foregut surgery during the current admission
* Oropharyngeal mucosal injury
* Placement of a tracheostomy
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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Principal Investigators
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Victoria J Fraser, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
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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American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
Kollef MH. Prevention of hospital-associated pneumonia and ventilator-associated pneumonia. Crit Care Med. 2004 Jun;32(6):1396-405. doi: 10.1097/01.ccm.0000128569.09113.fb.
Ruemmele FM, Bier D, Marteau P, Rechkemmer G, Bourdet-Sicard R, Walker WA, Goulet O. Clinical evidence for immunomodulatory effects of probiotic bacteria. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):126-41. doi: 10.1097/MPG.0b013e31817d80ca.
de Smet AM, Hopmans TE, Minderhoud AL, Blok HE, Gossink-Franssen A, Bernards AT, Bonten MJ. Decontamination of the digestive tract and oropharynx: hospital acquired infections after discharge from the intensive care unit. Intensive Care Med. 2009 Sep;35(9):1609-13. doi: 10.1007/s00134-009-1554-9. Epub 2009 Jun 24.
Oostdijk EA, de Smet AM, Blok HE, Thieme Groen ES, van Asselt GJ, Benus RF, Bernards SA, Frenay IH, Jansz AR, de Jongh BM, Kaan JA, Leverstein-van Hall MA, Mascini EM, Pauw W, Sturm PD, Thijsen SF, Kluytmans JA, Bonten MJ. Ecological effects of selective decontamination on resistant gram-negative bacterial colonization. Am J Respir Crit Care Med. 2010 Mar 1;181(5):452-7. doi: 10.1164/rccm.200908-1210OC. Epub 2009 Dec 3.
Other Identifiers
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201106182
Identifier Type: -
Identifier Source: org_study_id