Phase 2 N=96 Prevention

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

Lower Urinary Tract Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT02748317 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

May 2020

Primary outcome: Primary: Lactobacillus Safety — .594 Adverse Events — p==0.219

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lactobacillus rhamnosus GG (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medstar Health Research Institute
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Lactobacillus Safety	.594	=0.219
SECONDARY Lactobacillus Tolerability	60.6	—

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

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).

View full record on ClinicalTrials.gov →

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.