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)

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)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000512022

Acronym

ProSCIUTTU

Enrollment

207

Registered

2010-06-21

Start date

2011-04-04

Completion date

2013-09-04

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to evaluate the effectiveness of probiotics in reducing the recurrancce of urinary tract infection (UTI) in people with spinal cord injury and other neurological disorders. It is hypothesised that probiotics reduce the incidence of UTI.

Interventions

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)

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Healthy volunteers

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).

Outcome results