Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB

Completed · Phase 2

Conditions studied: Lower Urinary Tract Symptoms

In brief

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.

Key facts

Study ID

NCT02748317

Run by

Medstar Health Research Institute

People needed

96

Starts

2016-01-01

Expected to finish

2018-10-31

Last updated by the study team

2020-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Pregnant or breastfeeding
• Individuals with a history of acquired or genetic immunodeficiencies; active, acute or chronic serious infections (i.g., viral hepatitides, HIV/AIDs)
• Individuals with cancer/autoimmune disorders
• Serious allergy to any component or excipients in the live bacterial combination product
• No change in neurologic status in the previous 2 weeks
• Taken antibiotic for any reason in the previous 2 weeks
• Any patient with history of sensitivity or allergy to ampicillin or tetracycline
• Current urinary tract infection or urinary tract infection within the previous 2 weeks (as defined by Infectious Diseases Society of America CAUTI Guidelines, 2010).

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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