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Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
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.
Details
| Lead sponsor | Medstar Health Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 182 |
| Start date | 2020-01-10 |
| Completion | 2026-09 |
Conditions
- Neurogenic Bladder
Interventions
- Culturelle 10 Billion CFU Capsule
Primary outcomes
- Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter — (SA 1) day of urine collection
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) - Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter — (SA 1) day 1 post urine collection
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) - Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter — (SA 1) day 2 post urine collection
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) - Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter — (SA 1) day 3 post urine collection
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only) - Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter — (SA 2) Weekly up to 29 months
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes - Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter — (SA 2) day 1 of intervention (low or high dose)
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Countries
United States