Phase 2 N=7 Prevention

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

Lower Urinary Tract Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT02748356 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Apr 2020

Primary outcome: Primary: Lactobacillus Safety — .286 Adverse Events — p==0.351

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lactobacillus (Drug)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: Medstar Health Research Institute
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Lactobacillus Safety	.286	=0.351
SECONDARY Lactobacillus Tolerability	73.6	—

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

Age ≥6 years, and
Spina bifida and neuropathic bladder, as determined by the attending physician, and
Utilization of intermittent catheterization for bladder management, and
History of 2 or more urinary tract infections (UTIs) in the past year, and
Community dwelling.

Exclusion Criteria

Has a known genitourinary pathology beyond neuropathic bladder (e.g. vesicoureteral reflux, bladder stones, kidney stones, etc), and/or
Uses prophylactic antibiotics, and/or
Uses intravesicular agents to reduce UTI (e.g. gentamycin), and/or
Has psychologic or psychiatric conditions influencing the ability to follow instructions, and/or
Participates in another study in which results would be confounded, and/or
Is pregnant or breastfeeding, and/or
Has a history of acquired or genetic immunodeficiencies, or active, acute or chronic serious infections (e.g. viral hepatitides, HIV/AIDs), and/or
Has cancer or an autoimmune disorder, and/or
Has a serious allergy to any component or excipients in the live bacterial combination product, and/or
Has had a change in neurologic status in the previous 2 weeks, and/or
Has taken antibiotic for any reason in the previous 2 weeks, and/or
Has a history of sensitivity or allergy to ampicillin or tetracycline, and/or
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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02748356). 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.