Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
Who is this study for? Patients with Spinal Cord Injuries, Neurogenic Bladder
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years;
• SCI at least 6 months duration;
• NLUTD (as determined by their SCI physician or urologist);
• Utilizing intermittent catheterization for bladder management; and
• Community dwelling (discharged from the acute care setting).
Locations
United States
Washington, D.c.
MedStar National Rehabilitation Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Emily Leonard, PhD
emily.m.leonard@medstar.net
(202) 877-1844
Backup
Inger H Ljungberg, MPH
inger.h.ljungberg@medstar.net
(202) 877-1694
Time Frame
Start Date: 2022-06-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, participants will be instructed to mix the contents of 1 LGG® capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG® mixture into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months.
Other: Intravesical Bladder Wash (Treatment Phase)
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months.
Experimental: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase)
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, participants will be instructed to mix the contents of 1 LGG® capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG® mixture into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. They will then instill the LGG® mixture every 2 days for the remainder of the 6 months. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months.
Other: Intravesical Bladder Wash (Prophylaxis Phase)
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. They will then instill the saline BW every 2 days for the remainder of the 6 months. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months.
Related Therapeutic Areas
Sponsors
Leads: Medstar Health Research Institute