A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01632462|
Recruitment Status : Unknown
Verified August 2014 by Erasmo Miele, Federico II University.
Recruitment status was: Recruiting
First Posted : July 3, 2012
Last Update Posted : August 12, 2014
Federico II University
Information provided by (Responsible Party):
Erasmo Miele, Federico II University
No Study Results Posted on ClinicalTrials.gov for this Study
|Recruitment Status :||Unknown|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||February 2015|
Elson CO, Cong Y, Weaver CT, Schoeb TR, McClanahan TK, Fick RB, Kastelein RA. Monoclonal anti-interleukin 23 reverses active colitis in a T cell-mediated model in mice. Gastroenterology. 2007 Jun;132(7):2359-70. Epub 2007 Apr 13.
Sartor RB. The influence of normal microbial flora on the development of chronic mucosal inflammation. Res Immunol. 1997 Oct-Dec;148(8-9):567-76. Review.
Frank DN, St Amand AL, Feldman RA, Boedeker EC, Harpaz N, Pace NR. Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases. Proc Natl Acad Sci U S A. 2007 Aug 21;104(34):13780-5. Epub 2007 Aug 15.
Visekruna A, Joeris T, Schmidt N, Lawrenz M, Ritz JP, Buhr HJ, Steinhoff U. Comparative expression analysis and characterization of 20S proteasomes in human intestinal tissues: The proteasome pattern as diagnostic tool for IBD patients. Inflamm Bowel Dis. 2009 Apr;15(4):526-33. doi: 10.1002/ibd.20805.
Pagnini C, Saeed R, Bamias G, Arseneau KO, Pizarro TT, Cominelli F. Probiotics promote gut health through stimulation of epithelial innate immunity. Proc Natl Acad Sci U S A. 2010 Jan 5;107(1):454-9. doi: 10.1073/pnas.0910307107. Epub 2009 Dec 14.
Di Giacinto C, Marinaro M, Sanchez M, Strober W, Boirivant M. Probiotics ameliorate recurrent Th1-mediated murine colitis by inducing IL-10 and IL-10-dependent TGF-beta-bearing regulatory cells. J Immunol. 2005 Mar 15;174(6):3237-46.
Round JL, Mazmanian SK. The gut microbiota shapes intestinal immune responses during health and disease. Nat Rev Immunol. 2009 May;9(5):313-23. doi: 10.1038/nri2515. Review. Erratum in: Nat Rev Immunol. 2009 Aug;9(8):600.
Geddes K, Philpott DJ. A new role for intestinal alkaline phosphatase in gut barrier maintenance. Gastroenterology. 2008 Jul;135(1):8-12. doi: 10.1053/j.gastro.2008.06.006. Epub 2008 Jun 10. Review.
Reiff C, Delday M, Rucklidge G, Reid M, Duncan G, Wohlgemuth S, Hörmannsperger G, Loh G, Blaut M, Collie-Duguid E, Haller D, Kelly D. Balancing inflammatory, lipid, and xenobiotic signaling pathways by VSL#3, a biotherapeutic agent, in the treatment of inflammatory bowel disease. Inflamm Bowel Dis. 2009 Nov;15(11):1721-36. doi: 10.1002/ibd.20999.
Uronis JM, Arthur JC, Keku T, Fodor A, Carroll IM, Cruz ML, Appleyard CB, Jobin C. Gut microbial diversity is reduced by the probiotic VSL#3 and correlates with decreased TNBS-induced colitis. Inflamm Bowel Dis. 2011 Jan;17(1):289-97. doi: 10.1002/ibd.21366.