Phase 2
Completed N=96
Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB
Source: ClinicalTrials.gov NCT02748317 ↗Enrolled (actual)
96
Serious AEs
33.3%
Results posted
May 2020
Primary outcomePrimary: Lactobacillus Safety — .594 Adverse Events — p==0.219
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lactobacillus Safety |
.594 | =0.219 |
| SECONDARY Lactobacillus Tolerability |
60.6 | — |
Eligibility Criteria
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
- 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).
Data sourced from ClinicalTrials.gov (NCT02748317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.