Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB (NCT02748317) | Clinical Trial Compass
CompletedPhase 2
Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB
United States96 participantsStarted 2016-01
Plain-language summary
As a collaborative effort between MedStar National Rehabilitation Hospital (NRH)/MedStar Health Research Institute (MHRI), Children's National Medical Center (CNMC) Department of Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research, and Georgetown University Medical Center, the overall objective of this study is to develop, validate, and assess a patient-initiated, probiotics-based, self management protocol that is initiated at the time of urinary symptoms. The self-management protocol will allow patients to manage urinary symptoms and avoid potentially unnecessary antibiotic use, and provide a readily-available means of maintaining health, function, and independence throughout the lifespan.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age≥18 years
✓. SCI, SB or MS at least 1-year duration
✓. Neuropathic bladder, as determined by the attending physician
✓. Utilizing intermittent catheterization for bladder management
✓. A history of 2 or more UTIs in the past year
✓. Community dwelling.
Exclusion criteria
✕. Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.)
✕. Use of prophylactic antibiotics
✕. Instillation of intravesicular agents to reduce UTI (i.e., gentamycin)
✕. Psychologic or psychiatric conditions influencing the ability to follow instructions
✕. Participation in another study in which results would be confounded
✕. Individuals with a history of acquired or genetic immunodeficiencies; active, acute or chronic serious infections (i.g., viral hepatitides, HIV/AIDs)