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NCT07643974 · ClinicalTrials.gov registry record · Early Phase 1
Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
A Early Phase 1 study, sponsored by Medstar Health Research Institute.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 48
- Enrollment target
NCT07643974: Clinical Trial Early Phase 1 study, sponsored by Medstar Health Research Institute.
NCT07643974 is a Early Phase 1 study that has not yet begun recruiting, run by Medstar Health Research Institute. The registered enrollment target is 48 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07643974, a Early Phase 1 study, has not yet begun recruiting, sponsored by Medstar Health Research Institute.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The main objective of the proposed research study is to determine in men and women with spinal cord injury/disease and neurogenic bladder whether the dose of coupled gentamicin \& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Secondary objectives include determining whether that recolonization lasts 7, 14, or 28 days; and safety of the coupled gentamicin \& Lactobacillus instillations.
Primary Outcome
Urine samples will be analyzed with qPCR to determine whether LGG is present and, if so, at what concentration. Concentration from 24 hours after final LGG instillation will be compared to that measured after final gentamicin instillation. An increase of 30% or greater from baseline will be considered successful recolonization if LGG is present at baseline, otherwise absolute increase will be used.
Interventions
- DRUG Gentamicin
- DRUG Lactobacillus Rhamnosus GG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-06 |
| Est. Completion | 2027-09 |
| Phase | Early Phase 1 |
What is known before NCT07643974 opens enrollment
NCT07643974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Gentamicin is the first listed.
NCT07643974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07643974 about?
NCT07643974 is a clinical study titled "Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD". The main objective of the proposed research study is to determine in men and women with spinal cord injury/disease and neurogenic bladder whether the dose of coupled gentamicin \& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Se...
What is the current status of trial NCT07643974?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 48 participants. The study started on 2026-06. Estimated completion is 2027-09.
What interventions are being tested in trial NCT07643974?
The interventions under investigation include: Gentamicin (DRUG), Lactobacillus Rhamnosus GG (DRUG).
Who is sponsoring clinical trial NCT07643974?
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 NCT07643974's enrollment target sits among peer trials
48 541st of 2000 higher than 1,438 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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