Spinal Cord Injury Clinical Trial
Official title:
Colonizing Neurogenic Bladders With Benign Flora
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02574572 -
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
|
Phase 1 | |
Recruiting |
NCT05941819 -
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
|
N/A | |
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01471613 -
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
Completed |
NCT01025609 -
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
|
||
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 |