The Impact of Self-Management With Probiotics on Urinary Symptoms and the Urine Microbiome in Individuals With Spinal Cord Injury (SCI) and Spina Bifida (SB)

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• 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.

Locations
United States
Washington, D.c.
Children's National Medical Center
Washington
MedStar National Rehabilitation Hospital
Washington
Time Frame
Start Date: 2016-01
Completion Date: 2018-12-31
Participants
Target number of participants: 7
Treatments
Experimental: Individuals with Spina Bifida
Lactobacillus rhamnosus GG
Sponsors
Collaborators: Children's National Research Institute, Georgetown University, Patient-Centered Outcomes Research Institute
Leads: Medstar Health Research Institute

This content was sourced from clinicaltrials.gov