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Compares treatment options for Spinal Cord Injuries
Official title Intravesical LGG VS Saline Bladder Wash RCT
ClinicalTrials.gov ID: NCT05230511
What this study is testing
What is Lactobacillus RhamnosusGG?
Lactobacillus RhamnosusGG is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for spinal cord injuries.
Also referred to as Culturelle Probiotic LGG®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years;
- SCI at least 6 months duration;
- NLUTD (as determined by their SCI physician or urologist);
- Utilizing intermittent catheterization for bladder management; and
- Community dwelling (discharged from the acute care setting).
You likely can't join if
- Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);
- Use of prophylactic antibiotics;
- Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);
- Immunodeficiency;
- Any oral antibiotics within the past 2 weeks;
- Psychologic or psychiatric conditions influencing the ability to follow instructions;
See the full eligibility criteria
- Age ≥18 years;
- SCI at least 6 months duration;
- NLUTD (as determined by their SCI physician or urologist);
- Utilizing intermittent catheterization for bladder management; and
- Community dwelling (discharged from the acute care setting).
- Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);
- Use of prophylactic antibiotics;
- Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);
- Immunodeficiency;
- Any oral antibiotics within the past 2 weeks;
- Psychologic or psychiatric conditions influencing the ability to follow instructions;
- Participation in another study in which results would be confounded;
- 6 months since prior exposure to intravesical LGG®; and
- Active cancer (or within 5 years) or active autoimmune disorder
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.