Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB
Condition: Lower Urinary Tract Symptoms
MeSH terms: Spinal Cord Injuries; Lower Urinary Tract Symptoms
Intervention: Lactobacillus rhamnosus GG
Intervention description: For the intravesicular Lactobacillus instillation, participants will be instructed to mix the contents of 1 Lactobacillus capsule into 45 cc sterile 0.9% saline.5,6 After mixing, participants will draw up the 45 cc of the liquid Lactobacillus mixture into a 60cc catheter tip syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 10 Lactobacillus GG tabs at the beginning of treatment phase. At the end of each month, the coordinator or RA will ask how many remaining tablets the participant has, and if needed dispense the next supply of 10 tablets Participants will be instructed to complete the USQ-NB weekly.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spina Bifida; Spinal Cord Injury; Lower Urinary Tract Symptoms; Probiotics; Intermittent Catheterization

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age≥18 years

          2. SCI, SB or MS at least 1-year duration

          3. Neuropathic bladder, as determined by the attending physician

          4. Utilizing intermittent catheterization for bladder management

          5. A history of 2 or more UTIs in the past year

          6. Community dwelling.

        Exclusion Criteria:

          1. Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux,
             bladder or kidney stones, etc.)

          2. Use of prophylactic antibiotics

          3. Instillation of intravesicular agents to reduce UTI (i.e., gentamycin)

          4. Psychologic or psychiatric conditions influencing the ability to follow instructions

          5. Participation in another study in which results would be confounded

          6. Pregnant or breastfeeding

          7. Individuals with a history of acquired or genetic immunodeficiencies; active, acute or
             chronic serious infections (i.g., viral hepatitides, HIV/AIDs)

          8. Individuals with cancer/autoimmune disorders

          9. Serious allergy to any component or excipients in the live bacterial combination
             product

         10. No change in neurologic status in the previous 2 weeks

         11. Taken antibiotic for any reason in the previous 2 weeks

         12. Any patient with history of sensitivity or allergy to ampicillin or tetracycline

         13. Current urinary tract infection or urinary tract infection within the previous 2 weeks
             (as defined by Infectious Diseases Society of America CAUTI Guidelines, 2010).