Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria

Drug

Bladder health/function

Online since 25 January 2025, updated 5 days ago

About this trial

This trial is enrolling 30 participants with spinal cord injury to test the effect of personalized bacteriophage therapy on bladder health. Bacteriophages are viruses that specifically infect and kill bacteria. If included, participants will receive either a customized phage cocktail or a placebo, instilled into the bladder via catheter twice daily for 7 days. Final assessments of safety and tolerability will be performed after 35 days.

Included participants

Gender

All

Age

≥ 18 years

Injury level

C1 - S5

Severity (AIS)?

Time since injury

All

Healthy volunteers

C1-S5

Additionally, participants must

Require an indwelling (transurethral or suprapubic) or intermittent catheterization for bladder drainage.

Be currently receiving inpatient or outpatient SCI care at the Baylor College of Medicine

NOT have medical devices in the urinary tract (other than urinary catheters)

What’s involved

Type

Drug

Details

- Participants will receive either a customized phage cocktail or a placebo, instilled into the bladder via catheter twice daily for 7 days. - Phages are viruses that specifically infect and kill bacteria. - Final assessments of safety and tolerability will be performed after 35 days.

Potential benefits

Main benefits

Bladder health/function

Additional benefits

General health

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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