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
Intervention description: Eligible patients will undergo 1 Lactobacillus pediatric dose (Culturelle GG 10 Billion live organisms) instillation by study personnel at the study site. For the intravesicular Lactobacillus instillation, the contents of 1 Lactobacillus capsule will be mixed into sterile 0.9% saline using an age-based estimate of bladder capacity. Similar to adults, this bladder instillation will represent 10% of the estimated maximum bladder volume based on age.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Spina Bifida; Spinal Cord Injury

Summary:

      As a collaborative effort between MedStar National Rehabilitation Hospital (NRH), Children's
      National Medical Center (CNMC) Department of Urology, Children's Research Institute (CRI)
      Center for Genetic Medicine Research, Georgetown University, and MedStar Georgetown
      University Hospital, the overall objective of this study is to develop, validate, and assess
      a patient-initiated, probiotic-based, selfmanagement 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 ≥6 years, and

          2. Spina bifida and neuropathic bladder, as determined by the attending physician, and

          3. Utilization of intermittent catheterization for bladder management, and

          4. History of 2 or more urinary tract infections (UTIs) in the past year, and

          5. Community dwelling.

        Exclusion Criteria:

          1. Has a known genitourinary pathology beyond neuropathic bladder (e.g. vesicoureteral
             reflux, bladder stones, kidney stones, etc), and/or

          2. Uses prophylactic antibiotics, and/or

          3. Uses intravesicular agents to reduce UTI (e.g. gentamycin), and/or

          4. Has psychologic or psychiatric conditions influencing the ability to follow
             instructions, and/or

          5. Participates in another study in which results would be confounded, and/or

          6. Is pregnant or breastfeeding, and/or

          7. Has a history of acquired or genetic immunodeficiencies, or active, acute or chronic
             serious infections (e.g. viral hepatitides, HIV/AIDs), and/or

          8. Has cancer or an autoimmune disorder, and/or

          9. Has a serious allergy to any component or excipients in the live bacterial combination
             product, and/or

         10. Has had a change in neurologic status in the previous 2 weeks, and/or

         11. Has taken antibiotic for any reason in the previous 2 weeks, and/or

         12. Has a history of sensitivity or allergy to ampicillin or tetracycline, and/or

         13. Has a current urinary tract infection or urinary tract infection within the previous 2
             weeks (as defined by Infectious Diseases Society of America CAUTI Guidelines, 2010).