Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB
Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB
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.
Lower urinary symptoms are a common issue for individuals with neurogenic bladder, commonly
 occurring in the Spina bifida and Spinal Cord Injury population. In this study, probiotics
 will be introduced into the bladder to prevent UTIs. Introduction of probiotics will be
 determined by a validated symptom questionnaire (USQ-NB) and protocol (SMP-PRO).

 This study will estimate the strength of the associations between successful implementation
 of the probiotic self-management program (USQ-NB and SMP-PRO) and urinary symptoms, bladder
 inflammation, and the urine microbiome. Investigators will conduct an 18-month study in which
 each participant will serve as his/her own control through 3 phases of study: 6-months usual
 care (baseline), 6-months probiotic intervention, and 6-months follow-up.

 Participants will complete the Urinary Symptom Questionnaire weekly. After 6 months of
 baseline data collection, participants will receive the Lactobacillus (Culturelle GG, 20
 billion live organisms for adults and 10 billion live organisms for children <18 years of
 age), will be instructed on preparation and intravesicular instillation of the Lactobacillus,
 and will have a tutorial with a fellow consumer on use of the patient-initiated protocol. The
 protocol and Lactobacillus bladder instillation instructions (including a step-by-step video)
 will be available on the study website for 24/7 access and written instructions will be
 provided at the time of instruction.

 For the intravesicular Lactobacillus instillation, participants will be instructed to mix the
 contents into sterile saline. After mixing, participants will draw up the liquid
 Lactobacillus mixture into a 60cc catheter tip syringe and instill via the intermittent
 catheter after fully emptying the bladder. The amount instilled is determined by the age of
 the child. Participants will be instructed not to catheterize for at least 4 hours after the
 bladder instillation. Participants will receive 10 Culturelle GG at the beginning of the
 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.

 If/when urinary symptoms occur, subjects will be instructed to follow the protocol to
 determine whether to initiate intravesicular Lactobacillus instillation or be evaluated by a
 physician. The self-management protocol will also direct them to discontinue Lactobacillus
 instillation or be evaluated by a physician if symptoms remit, persist (after 2
 instillations), or worsen. The maximum number of instillations is 2 over 28 hours. If
 participants are directed by the self-management protocol to seek medical attention or s/he
 feels the need for medical evaluation, s/he will be advised to obtain care as they typically
 would by their health care provider. Participants will be supplied with letters to be brought
 to their health care provider notifying them of the study and requesting sharing of
 urinalysis and urine culture results with the research team. A verified UTI will include
 those that resulted in antibiotic treatment by a health care professional. An additional
 urine sample for metagenomics will either be left with the health care provider for pick up
 by the research team, brought to the research site, or obtained by the RA at a mutually
 convenient site.

 After completion of the 6-month patient-initiated self-management protocol intervention
 period, participants will monitor symptoms weekly using the USQ-NB.
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).