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NCT04373512 · ClinicalTrials.gov registry record · Phase 2
Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury
A Phase 2 study, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 182
- Enrollment target
NCT04373512: Completed Phase 2 study, sponsored by Medstar Health Research Institute.
NCT04373512 is a Phase 2 study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 182 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04373512, a Phase 2 study, has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 182 participants
- Enrollment target
Study 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.
Primary Outcome
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Interventions
- DRUG Culturelle 10 Billion CFU Capsule (2 doses)
- DRUG Culturelle 10 Billion CFU Capsule (4 doses)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2020-05-20 |
| Est. Completion | 2025-02-14 |
| Phase | Phase 2 |
What the finished NCT04373512 record still lists
NCT04373512 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Culturelle 10 Billion CFU Capsule (2 doses) is the first listed.
NCT04373512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04373512 about?
NCT04373512 is a clinical study titled "Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury". 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 intrave...
What is the current status of trial NCT04373512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2020-05-20. Estimated completion is 2025-02-14.
What interventions are being tested in trial NCT04373512?
The interventions under investigation include: Culturelle 10 Billion CFU Capsule (2 doses) (DRUG), Culturelle 10 Billion CFU Capsule (4 doses) (DRUG).
Who is sponsoring clinical trial NCT04373512?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04373512's enrollment target sits among peer trials
182 363rd of 2000 higher than 1,636 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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