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Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 21, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Site details revised
    v10
  2. Primary and study completion dates: Sep 2025 to Sep 2026
    • Site contact updated
    v9
  3. Primary completion date: Dec 2024 to Sep 2025
    • Site contact updated
    v8
  4. Primary completion date: Oct 2024 to Dec 2024
    • Study completion date: Oct 2024 to Sep 2025
    v7
  5. Phase: Phase 3 to Phase 2v6
Show 4 earlier versionsHide 4 earlier versions
  1. 2 versions Re-verified since Jun 8, 2021, no change to tracked fieldsv4-v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2020 to Jan 10, 2020
    v3
  3. Primary endpoints: 29 to 35v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04323735
Lead Sponsor Medstar Health Research Institute
Collaborators: Children's National Research Institute
Conditions
(from sponsor)		 Neurogenic Bladder
Related terms Urinary Bladder, Neurogenic
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov