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

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute
• Collaborators: Children's National Research Institute; Children's Research Institute; Georgetown University; Patient-Centered Outcomes Research Institute

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).