Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
Who is this study for? People with NLUTD who use indwelling catheters
What treatments are being studied? Culturelle
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Neurogenic bladder for at least 6 months;
• Utilizing indwelling catheterization for bladder management;
• Women must be premenopausal and not currently menstruating;
• Community dwelling
• physical disability
Locations
United States
Washington, D.c.
MedStar National Rehabilitation Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Amanda K Rounds, PhD
Amanda.K.Rounds@medstar.net
202-877-1591
Backup
Inger H Ljungberg
Inger.H.Ljungberg@medstar.net
202-877-1694
Time Frame
Start Date: 2020-01-10
Estimated Completion Date: 2026-09
Participants
Target number of participants: 182
Treatments
Active_comparator: Low Dosage
For the LGG® instillation, 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 indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. Participants will receive 2 \]LGG capsules and will repeat this process the following day (Low dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion.
Active_comparator: High dosage
For the LGG® instillation, 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 indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. Participants will receive 4 LGG capsules and will repeat this process the following day twice for a total of four doses (High dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion.
Related Therapeutic Areas
Sponsors
Collaborators: Children's National Research Institute
Leads: Medstar Health Research Institute