A multicentre 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)

Completed

• Conditions: People with spinal cord injury suffering from recurrent urinary tract infection resulting from multi-resistant organisms.; People with stable multiple sclerosis or cerebral vascular disease, with documented neurogenic bladder on video urodynamic assessment, who also suffer from recurrent urinary tract infection resulting from multi-resitant organisms.; Renal and Urogenital - Other renal and urogenital disorders; Infection - Studies of infection and infectious agents; Neurological - Other neurological disorders

• Registration Number: ACTRN12610000512022
• Lead Sponsor: Dr Bon San Bonne Lee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-21
• Study Completion: 2014-03-04
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Subjects may be included if they:
1.have a spinal cord injury defined as stable, non progressive Spinal Cord Injury with a neuropathic bladder”;
2.have stable multiple sclerosis or cerebral vascular disease with documented neurogenic bladder on video urodynamic assessment;
3.have stable bladder management technique (i.e. not receiving bladder management education for at least 4 weeks) and using a bladder management technique such as indwelling catheter, suprapubic catheter, clean intermittent self-catheterisation or condom drainage;
4.have given written informed consent, and agreed to fortnightly telephone follow-up for themselves and their care team for the study period;
5.have agreed not to take any other probiotic in addition to the allocated intervention. This includes all yogurt oral or topical preparations.

Exclusion Criteria

Subjects will be excluded if they are:
1.receiving bladder management education;
2.being treated for, or symptomatic of a current infection or long-standing pressure sore;
3.known to have a complex bladder disturbance requiring surgical intervention e.g. known cystoplasty, renal or bladder calculus, significant hydronephrosis, or pyelonephritis;
4.known to have chronic open wound/s or known long-standing osteomyelitis (greater than 6 weeks);
5.on long-term antibiotic therapy for any indication;
6.on steroids or interferon B therapy;
7.known to have a history of adverse drug reaction to yoghurt or milk products or a demonstrated intolerance to the probiotics used. Lactose intolerance is NOT an exclusion criterion;
8.known to have severe renal or hepatic failure; full (invasive) mechanical ventilation
9.receiving immunosuppressant medications or have an underlying immunosuppressive disease (for example Human Immuno-deficiency Virus (HIV) or end-stage/ progressive diabetes mellitus, multiple sclerosis or cerebrovascular disease).
10.planning to have oral surgery during the intervention period,
11.known to be colonised and have laboratory evidence with either a positive culture on rectal, nares, urine and groin swabs of one or more of the following organisms: multi-resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE), extended spectrum beta lactamase producing (ESBL) gram negative organisms and carbapenem resistant Acinetobacter spp AND have laboratory evidence of an infection.
12.concurrently enrolled in another intervention study; (observational studies or inclusion following completion of another study is allowed).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first symptomatic urinary tract infection and total number of urinary tract infection over the 6 month period.[Time to symptomatic urinary tract infection or otherwise trial endpoint of 6 months. Urine cultures obtained at 0, 4, 8, 12 and 24 week timepoints, additional urine culture obtained at time of symptomatic urinary tract infection.]

Secondary Outcome Measures

Name	Time	Method
Change of multi-resistant organism colonisation status in the nares, rectum, groin or urine.[Cultures obtained at 0, 4, 8, 12 and 24 week timepoints.];Quality of life measure with economic evaluation using the SF36, SF36walk-wheel and SF6D questionairre.[0 and 24 weeks, plus at symptomatic urinary tract infection diagnosis and 4 weeks post this.];St Marks Incontinence, Cleveland Constipation, Basic and Extended International Bowel Surveys.[0 and 12 week timepoints.]