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. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2

ProSCIUTTU Study 2014.

Trial name or title A multicenter randomised double‐blind, double‐dummy placebo‐controlled study to assess the efficacy, safety and cost‐utility of Probiotic prophylaxis of spinal cord injury Urinary Tract Infection. A Therapeutic Trial (ProSCIUTTU)
Methods Double‐blind, multicenter, double‐dummy, randomised, placebo‐controlled study
Participants Men or women with spinal cord injury suffering from recurrent UTI resulting from multi‐resistant organisms. Men or women with stable multiple sclerosis or cerebral vascular disease, with documented neurogenic bladder on video urodynamic assessment, who also suffer from recurrent UTI resulting from multi‐resistant organisms. For complete inclusion and exclusion criteria see http://www.anzctr.org.au/ACTRN12610000512022.aspx
Interventions Oral probiotic, two lactobacillus/Bifidobacterium capsules daily for six months
Oral placebo, two capsules daily for six months
Outcomes Primary
  • Time to first symptomatic UTI and total number of UTIs over the six month period


Secondary
  • Change of multi‐resistant organism colonisation status in the nares, rectum, groin or urine

  • Quality of life measure with economic evaluation using the SF36, SF36 walk‐wheel and SF6D questionnaire

  • St Marks Incontinence, Cleveland Constipation, Basic and Extended International Bowel Surveys

Starting date August 2010
Contact information Dr Bon San Bonne Lee
Spinal Injuries Unit, Prince of Wales Hospital, Randwick, Australia
Notes Email sent 26 March 2013 requesting study publication or an update

UTI ‐ urinary tract infection