Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000512022
Ethics application status
Approved
Date submitted
21/06/2010
Date registered
21/06/2010
Date last updated
18/01/2023
Date data sharing statement initially provided
18/01/2023
Date results provided
18/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
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)
Scientific title
A multicentre randomised, placebo-controlled study to assess the efficacy, safety and cost utility of probiotic prophylaxis on urinary tract infection in people with spinal cord injury, stable multiple sclerosis or cerebral vascular disease. (ProSCIUTTU)
Secondary ID [1] 251975 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
ProSCIUTTU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with spinal cord injury suffering from recurrent urinary tract infection resulting from multi-resistant organisms. 257536 0
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. 257608 0
Condition category
Condition code
Renal and Urogenital 257699 257699 0 0
Other renal and urogenital disorders
Infection 257700 257700 0 0
Studies of infection and infectious agents
Neurological 257783 257783 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral probiotic therapy of two capsules daily for six months. Each capsule will contain either 1) Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 (GR1-RC14) (2.7 × 10^9 colony forming units (cfu)) OR 2) Lactobacillus rhamnosus GG (LGG) and bifidobacterium (BB-12) (3.5 × 10^9 cfu of each culture)
Intervention code [1] 256632 0
Prevention
Intervention code [2] 256633 0
Lifestyle
Comparator / control treatment
Placebo - two capsules daily for six months.
Placebo capsules are identical in size, shape, colour and taste to the active capsule. The capsule is made of Hypromellose, titanium dioxide. The capsule contains all of the same powder constituents (maltodextrin, microcrystalline cellulose, silicon dioxide and magnesium stearate) as the active capsule except for the active cultures.
Control group
Placebo

Outcomes
Primary outcome [1] 258648 0
Time to first symptomatic urinary tract infection and total number of urinary tract infection over the 6 month period.
Timepoint [1] 258648 0
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 [1] 264626 0
Change of multi-resistant organism colonisation status in the nares, rectum, groin or urine.
Timepoint [1] 264626 0
Cultures obtained at 0, 4, 8, 12 and 24 week timepoints.
Secondary outcome [2] 264627 0
Quality of life measure with economic evaluation using the SF36, SF36walk-wheel and SF6D questionairre.
Timepoint [2] 264627 0
0 and 24 weeks, plus at symptomatic urinary tract infection diagnosis and 4 weeks post this.
Secondary outcome [3] 276937 0
St Marks Incontinence, Cleveland Constipation, Basic and Extended International Bowel Surveys.
Timepoint [3] 276937 0
0 and 12 week timepoints.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
4/04/2011
Date of last participant enrolment
Anticipated
Actual
4/09/2013
Date of last data collection
Anticipated
Actual
4/03/2014
Sample size
Target
372
Accrual to date
Final
207
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257161 0
Government body
Name [1] 257161 0
National Health and Medical Research Council
Country [1] 257161 0
Australia
Primary sponsor type
Individual
Name
Dr Bon San Bonne Lee
Address
Spinal Injuries Unit
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 256417 0
Other Collaborative groups
Name [1] 256417 0
Neuroscience Research Australia
Address [1] 256417 0
Barker Street Randwick NSW 2031
Country [1] 256417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259202 0
Northern Sydney Central Coast HREC
Ethics committee address [1] 259202 0
Ethics committee country [1] 259202 0
Australia
Date submitted for ethics approval [1] 259202 0
08/07/2010
Approval date [1] 259202 0
03/11/2010
Ethics approval number [1] 259202 0
1008-282M

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31273 0
Dr Bon San Bonne Lee
Address 31273 0
Neuroscience Research Australia
Barker Street NSW
Randwick 2031
Country 31273 0
Australia
Phone 31273 0
+61 2 9382 5622
Fax 31273 0
Email 31273 0
[email protected]
Contact person for public queries
Name 14520 0
Bon San Bonne Lee
Address 14520 0
Spinal Injuries Unit
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 14520 0
Australia
Phone 14520 0
+61 2 9382 5622
Fax 14520 0
Email 14520 0
[email protected]
Contact person for scientific queries
Name 5448 0
Bon San Bonne Lee
Address 5448 0
Spinal Injuries Unit
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 5448 0
Australia
Phone 5448 0
+61 2 9382 5622
Fax 5448 0
Email 5448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProbiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a study protocol for a randomised controlled trial.2016https://dx.doi.org/10.1186/s12894-016-0136-8
EmbaseUrinary catheter-associated microbiota change in accordance with treatment and infection status.2017https://dx.doi.org/10.1371/journal.pone.0177633
EmbaseProbiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a randomised controlled trial.2019https://dx.doi.org/10.1038/s41393-019-0251-y
EmbaseEffect of probiotics on multi-resistant organism colonisation in persons with spinal cord injury: secondary outcome of ProSCIUTTU, a randomised placebo-controlled trial.2020https://dx.doi.org/10.1038/s41393-020-0420-z
N.B. These documents automatically identified may not have been verified by the study sponsor.