The Influence of Probiotics on Vancomycin-Resistant Enterococcus
NCT ID: NCT00591474
Last Updated: 2019-06-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
8 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-12-31
Study Completion Date
2010-06-30
Brief Summary
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Drinking probiotics in a the form of a yogurt drink will restore normal gastrointestinal (GI) bacteria in patients whose colon are colonized with vancomycin-resistant enterococcus (VRE).
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Detailed Description
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Conditions
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GI Colonization of Vancomycin-resistant Enterococcus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
OTHER
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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1
VRE positive patients
Group Type
EXPERIMENTAL
probiotics
Intervention Type
DIETARY_SUPPLEMENT
100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks
2
VRE positive patients
Group Type
PLACEBO_COMPARATOR
yogurt
Intervention Type
DIETARY_SUPPLEMENT
100 gms of pasteurized yogurt drinks with no live cultures will be given to VRE positive patients for 4 weeks
Interventions
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probiotics
100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks
Intervention Type
DIETARY_SUPPLEMENT
yogurt
100 gms of pasteurized yogurt drinks with no live cultures will be given to VRE positive patients for 4 weeks
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* VRE positive patients with GI colonization
Exclusion Criteria
* Age less than 18 years
* Patients who have had a bone marrow transplant
* Extreme short bowel patients (less than 100 cm small bowel remaining)
* Patients with active VRE infection but no GI colonization
* Patients unable to eat and have no feeding access
* Patients who do not have a power of attorney to give consent if they are unable to
* Patients who have had a bone marrow transplant
* Extreme short bowel patients (less than 100 cm small bowel remaining)
* Patients with active VRE infection but no GI colonization
* Patients unable to eat and have no feeding access
* Patients who do not have a power of attorney to give consent if they are unable to
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Oregon Health and Science University
OTHER
Sponsor Role
lead
Responsible Party
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Robert Martindale
MD, PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Robert Martindale, MD, PH.D
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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OHSU hospital
Portland, Oregon, United States
Site Status
Countries
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United States
References
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Vanderhoof JA, Whitney DB, Antonson DL, Hanner TL, Lupo JV, Young RJ. Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children. J Pediatr. 1999 Nov;135(5):564-8. doi: 10.1016/s0022-3476(99)70053-3.
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Alvarez-Olmos MI, Oberhelman RA. Probiotic agents and infectious diseases: a modern perspective on a traditional therapy. Clin Infect Dis. 2001 Jun 1;32(11):1567-76. doi: 10.1086/320518. Epub 2001 May 4.
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Sartor RB. Probiotic therapy of intestinal inflammation and infections. Curr Opin Gastroenterol. 2005 Jan;21(1):44-50.
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Pelz RK, Lipsett PA, Swoboda SM, Diener-West M, Powe NR, Brower RG, Perl TM, Hammond JM, Hendrix CW. Vancomycin-sensitive and vancomycin-resistant enterococcal infections in the ICU: attributable costs and outcomes. Intensive Care Med. 2002 Jun;28(6):692-7. doi: 10.1007/s00134-002-1276-8. Epub 2002 Apr 12.
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BACKGROUND
Weinstock DM, Conlon M, Iovino C, Aubrey T, Gudiol C, Riedel E, Young JW, Kiehn TE, Zuccotti G. Colonization, bloodstream infection, and mortality caused by vancomycin-resistant enterococcus early after allogeneic hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2007 May;13(5):615-21. doi: 10.1016/j.bbmt.2007.01.078. Epub 2007 Mar 23.
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Humphreys H, Dolan V, Sexton T, Conlon P, Rajan L, Creamer E, Walshe J, Donohoe J, Smyth EG. Implications of colonization of vancomycin-resistant enterococci (VRE) in renal dialysis patients. Learning to live with it? J Hosp Infect. 2004 Sep;58(1):28-33. doi: 10.1016/j.jhin.2004.04.022.
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Zaas AK, Song X, Tucker P, Perl TM. Risk factors for development of vancomycin-resistant enterococcal bloodstream infection in patients with cancer who are colonized with vancomycin-resistant enterococci. Clin Infect Dis. 2002 Nov 15;35(10):1139-46. doi: 10.1086/342904. Epub 2002 Oct 17.
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Patel R. Clinical impact of vancomycin-resistant enterococci. J Antimicrob Chemother. 2003 Jun;51 Suppl 3:iii13-21. doi: 10.1093/jac/dkg272.
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Kreman T, Hu J, Pottinger J, Herwaldt LA. Survey of long-term-care facilities in Iowa for policies and practices regarding residents with methicillin-resistant Staphylococcus aureus or vancomycin-resistant enterococci. Infect Control Hosp Epidemiol. 2005 Oct;26(10):811-5. doi: 10.1086/502498.
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BACKGROUND
Bryce EA, Tiffin SM, Isaac-Renton JL, Wright CJ. Evidence of delays in transferring patients with methicillin-resistant Staphylococcus aureus or vancomycin-resistant Enterococcus to long-term-care facilities. Infect Control Hosp Epidemiol. 2000 Apr;21(4):270-1. doi: 10.1086/501757.
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BACKGROUND
Baden LR, Thiemke W, Skolnik A, Chambers R, Strymish J, Gold HS, Moellering RC Jr, Eliopoulos GM. Prolonged colonization with vancomycin-resistant Enterococcus faecium in long-term care patients and the significance of "clearance". Clin Infect Dis. 2001 Nov 15;33(10):1654-60. doi: 10.1086/323762. Epub 2001 Oct 10.
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BACKGROUND
Dunne C. Adaptation of bacteria to the intestinal niche: probiotics and gut disorder. Inflamm Bowel Dis. 2001 May;7(2):136-45. doi: 10.1097/00054725-200105000-00010.
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BACKGROUND
Vanderhoof JA, Young RJ. Current and potential uses of probiotics. Ann Allergy Asthma Immunol. 2004 Nov;93(5 Suppl 3):S33-7. doi: 10.1016/s1081-1206(10)61730-9.
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BACKGROUND
McFarland LV. Meta-analysis of probiotics for the prevention of antibiotic associated diarrhea and the treatment of Clostridium difficile disease. Am J Gastroenterol. 2006 Apr;101(4):812-22. doi: 10.1111/j.1572-0241.2006.00465.x.
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BACKGROUND
Hickson M, D'Souza AL, Muthu N, Rogers TR, Want S, Rajkumar C, Bulpitt CJ. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. BMJ. 2007 Jul 14;335(7610):80. doi: 10.1136/bmj.39231.599815.55. Epub 2007 Jun 29.
Reference Type
BACKGROUND
Manley KJ, Fraenkel MB, Mayall BC, Power DA. Probiotic treatment of vancomycin-resistant enterococci: a randomised controlled trial. Med J Aust. 2007 May 7;186(9):454-7. doi: 10.5694/j.1326-5377.2007.tb00995.x.
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BACKGROUND
Hendrix CW, Hammond JM, Swoboda SM, Merz WG, Harrington SM, Perl TM, Dick JD, Borschel DM, Halczenko PW, Pelz RK, Rocco LE, Conway JE, Brower RG, Lipsett PA. Surveillance strategies and impact of vancomycin-resistant enterococcal colonization and infection in critically ill patients. Ann Surg. 2001 Feb;233(2):259-65. doi: 10.1097/00000658-200102000-00016.
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BACKGROUND
Carmeli Y, Eliopoulos G, Mozaffari E, Samore M. Health and economic outcomes of vancomycin-resistant enterococci. Arch Intern Med. 2002 Oct 28;162(19):2223-8. doi: 10.1001/archinte.162.19.2223.
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BACKGROUND
Patel R, Allen SL, Manahan JM, Wright AJ, Krom RA, Wiesner RH, Persing DH, Cockerill FR, Thompson RL. Natural history of vancomycin-resistant enterococcal colonization in liver and kidney transplant recipients. Liver Transpl. 2001 Jan;7(1):27-31. doi: 10.1053/jlts.2001.20784.
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BACKGROUND
Montecalvo MA, de Lencastre H, Carraher M, Gedris C, Chung M, VanHorn K, Wormser GP. Natural history of colonization with vancomycin-resistant Enterococcus faecium. Infect Control Hosp Epidemiol. 1995 Dec;16(12):680-5. doi: 10.1086/647041.
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BACKGROUND
Roghmann MC, Qaiyumi S, Schwalbe R, Morris JG Jr. Natural history of colonization with vancomycin-resistant Enterococcus faecium. Infect Control Hosp Epidemiol. 1997 Oct;18(10):679-80. doi: 10.1086/647510. No abstract available.
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BACKGROUND
Borriello SP, Hammes WP, Holzapfel W, Marteau P, Schrezenmeir J, Vaara M, Valtonen V. Safety of probiotics that contain lactobacilli or bifidobacteria. Clin Infect Dis. 2003 Mar 15;36(6):775-80. doi: 10.1086/368080. Epub 2003 Mar 5.
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BACKGROUND
Gorbach SL. Probiotics and gastrointestinal health. Am J Gastroenterol. 2000 Jan;95(1 Suppl):S2-4. doi: 10.1016/s0002-9270(99)00806-0.
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Vanderhoof JA. Probiotics: future directions. Am J Clin Nutr. 2001 Jun;73(6):1152S-1155S. doi: 10.1093/ajcn/73.6.1152S.
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Rayes N, Seehofer D, Theruvath T, Schiller RA, Langrehr JM, Jonas S, Bengmark S, Neuhaus P. Supply of pre- and probiotics reduces bacterial infection rates after liver transplantation--a randomized, double-blind trial. Am J Transplant. 2005 Jan;5(1):125-30. doi: 10.1111/j.1600-6143.2004.00649.x.
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BACKGROUND
Rayes N, Seehofer D, Hansen S, Boucsein K, Muller AR, Serke S, Bengmark S, Neuhaus P. Early enteral supply of lactobacillus and fiber versus selective bowel decontamination: a controlled trial in liver transplant recipients. Transplantation. 2002 Jul 15;74(1):123-7. doi: 10.1097/00007890-200207150-00021.
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Osterlund P, Ruotsalainen T, Korpela R, Saxelin M, Ollus A, Valta P, Kouri M, Elomaa I, Joensuu H. Lactobacillus supplementation for diarrhoea related to chemotherapy of colorectal cancer: a randomised study. Br J Cancer. 2007 Oct 22;97(8):1028-34. doi: 10.1038/sj.bjc.6603990. Epub 2007 Sep 25.
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BACKGROUND
Delia P, Sansotta G, Donato V, Messina G, Frosina P, Pergolizzi S, De Renzis C, Famularo G. Prevention of radiation-induced diarrhea with the use of VSL#3, a new high-potency probiotic preparation. Am J Gastroenterol. 2002 Aug;97(8):2150-2. doi: 10.1111/j.1572-0241.2002.05946.x. No abstract available.
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BACKGROUND
Rautio M, Jousimies-Somer H, Kauma H, Pietarinen I, Saxelin M, Tynkkynen S, Koskela M. Liver abscess due to a Lactobacillus rhamnosus strain indistinguishable from L. rhamnosus strain GG. Clin Infect Dis. 1999 May;28(5):1159-60. doi: 10.1086/514766. No abstract available.
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Mackay AD, Taylor MB, Kibbler CC, Hamilton-Miller JM. Lactobacillus endocarditis caused by a probiotic organism. Clin Microbiol Infect. 1999 May;5(5):290-292. doi: 10.1111/j.1469-0691.1999.tb00144.x. No abstract available.
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Land MH, Rouster-Stevens K, Woods CR, Cannon ML, Cnota J, Shetty AK. Lactobacillus sepsis associated with probiotic therapy. Pediatrics. 2005 Jan;115(1):178-81. doi: 10.1542/peds.2004-2137.
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Kunz AN, Noel JM, Fairchok MP. Two cases of Lactobacillus bacteremia during probiotic treatment of short gut syndrome. J Pediatr Gastroenterol Nutr. 2004 Apr;38(4):457-8. doi: 10.1097/00005176-200404000-00017. No abstract available.
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De Groote MA, Frank DN, Dowell E, Glode MP, Pace NR. Lactobacillus rhamnosus GG bacteremia associated with probiotic use in a child with short gut syndrome. Pediatr Infect Dis J. 2005 Mar;24(3):278-80. doi: 10.1097/01.inf.0000154588.79356.e6.
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Klare I, Konstabel C, Werner G, Huys G, Vankerckhoven V, Kahlmeter G, Hildebrandt B, Muller-Bertling S, Witte W, Goossens H. Antimicrobial susceptibilities of Lactobacillus, Pediococcus and Lactococcus human isolates and cultures intended for probiotic or nutritional use. J Antimicrob Chemother. 2007 May;59(5):900-12. doi: 10.1093/jac/dkm035. Epub 2007 Mar 16.
Reference Type
BACKGROUND
Other Identifiers
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IRB3848
Identifier Type: -
Identifier Source: org_study_id
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