Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371631
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2006-08-31
Brief Title:
Colonizing Neurogenic Bladders With Benign Flora
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Colonizing Neurogenic Bladders With Benign Flora
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the research is to determine whether we can get harmless bacteria to live in the bladders of persons with spinal cord injury who practice intermittent bladder catheterization We will also look at whether having the harmless bacteria in the bladder prevents urinary tract infections from occurring
Detailed Description:
The unifying goal of our work is to develop new approaches for the prevention of urinary tract infection UTI in persons with spinal cord injury SCI Most individuals with SCI have neurogenic bladders and the resulting urinary stasis and bladder catheterization predispose them to recurrent UTI Currently few if any measures are effective at prevention of UTI in persons with neurogenic bladders
Bacterial interference or using benign bacteria to prevent infection with virulent pathogens may offer a solution to the significant problem of recurrent episodes of UTI in persons with SCI Two trials in persons with SCI of instilling nonpathogenic Escherichia coli 83972 directly into the bladder demonstrated a strong association between colonization with this non-pathogen and decreased frequency of UTI However the successful colonization rate of the direct inoculation method was low 51-62 Since a urinary catheter-associated biofilm or bacteria plus extracellular matrix continually seeds the bladder with bacteria we proposed to use urinary catheters that had been pre-coated with a biofilm of E coli 83972 as a means to achieve bladder colonization Our recently completed pilot B3248P demonstrated that insertion of urinary catheters pre-coated with E coli 83972 was an effective and safe method to achieve bladder colonization with this potentially protective strain The rate of successful colonization with the E coli-coated catheters was high 10 of 12 subjects or 83 However this pilot was limited to the subpopulation of SCI veterans who utilize chronic indwelling catheters for bladder drainage
The current proposal expands upon previous work by widening the range of eligible subjects and by simplifying the colonization protocol Since an intermittent catheterization program ICP is a preferred and more common means of managing neurogenic bladders than chronic catheterization we now plan to test E coli 83972-coated catheters in persons with SCI who use ICP for bladder drainage We hypothesize that short-term use 3 days of E coli 83972-coated catheters in persons with SCI practicing ICP will lead to successful colonization persisting 28 days or more in the majority of subjects We will also record subjects rates of symptomatic UTI while colonized with E coli 83972 and compare these rates to the subjects baseline rates in the year prior to study entry Subjects will be able to remove their study catheters at home and to submit urine samples by mail so the colonization process will simple and convenient If successful colonization is achieved in this pilot trial a larger clinical trial will be designed to test the efficacy of these catheters at preventing UTI in persons with SCI
Bacterial interference or using benign bacteria to prevent infection with virulent pathogens may offer a solution to the significant problem of recurrent episodes of UTI in persons with SCI Two trials in persons with SCI of instilling nonpathogenic Escherichia coli 83972 directly into the bladder demonstrated a strong association between colonization with this non-pathogen and decreased frequency of UTI However the successful colonization rate of the direct inoculation method was low 51-62 Since a urinary catheter-associated biofilm or bacteria plus extracellular matrix continually seeds the bladder with bacteria we proposed to use urinary catheters that had been pre-coated with a biofilm of E coli 83972 as a means to achieve bladder colonization Our recently completed pilot B3248P demonstrated that insertion of urinary catheters pre-coated with E coli 83972 was an effective and safe method to achieve bladder colonization with this potentially protective strain The rate of successful colonization with the E coli-coated catheters was high 10 of 12 subjects or 83 However this pilot was limited to the subpopulation of SCI veterans who utilize chronic indwelling catheters for bladder drainage
The current proposal expands upon previous work by widening the range of eligible subjects and by simplifying the colonization protocol Since an intermittent catheterization program ICP is a preferred and more common means of managing neurogenic bladders than chronic catheterization we now plan to test E coli 83972-coated catheters in persons with SCI who use ICP for bladder drainage We hypothesize that short-term use 3 days of E coli 83972-coated catheters in persons with SCI practicing ICP will lead to successful colonization persisting 28 days or more in the majority of subjects We will also record subjects rates of symptomatic UTI while colonized with E coli 83972 and compare these rates to the subjects baseline rates in the year prior to study entry Subjects will be able to remove their study catheters at home and to submit urine samples by mail so the colonization process will simple and convenient If successful colonization is achieved in this pilot trial a larger clinical trial will be designed to test the efficacy of these catheters at preventing UTI in persons with SCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None