Comparing Lactobacillus Rhamnosus GG with saline bladder wash for preventing UTIs in spinal cord injury patients
Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
This study is testing if a special probiotic combined with a saline bladder wash can help prevent urinary tract infections in people with spinal cord injuries.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT05230511 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Lactobacillus Rhamnosus GG (LGG) combined with saline bladder wash compared to saline bladder wash alone in preventing urinary tract infections (UTIs) among individuals with spinal cord injuries and neurogenic bladder. The study focuses on self-management strategies for participants who experience specific urinary symptoms, such as cloudiness or foul odor. By addressing the diagnostic challenges associated with UTIs in this population, the trial seeks to provide a novel approach to managing urinary health without relying on antibiotics. Participants will be monitored for changes in bladder and urine quality as primary outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with spinal cord injuries lasting at least six months who manage their bladder through intermittent catheterization.
Not a fit: Patients with additional genitourinary pathologies, those using prophylactic antibiotics, or individuals with active cancer or autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of UTIs in patients with spinal cord injuries, improving their overall health and quality of life.
How similar studies have performed: While this approach is novel in the context of spinal cord injuries, similar studies have shown promise in using probiotics for UTI prevention in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years; 2. SCI at least 6 months duration; 3. NLUTD (as determined by their SCI physician or urologist); 4. Utilizing intermittent catheterization for bladder management; and 5. Community dwelling (discharged from the acute care setting). Exclusion Criteria: 1. Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.); 2. Use of prophylactic antibiotics; 3. Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus); 4. Immunodeficiency; 5. Any oral antibiotics within the past 2 weeks; 6. Psychologic or psychiatric conditions influencing the ability to follow instructions; 7. Participation in another study in which results would be confounded; 8. 6 months since prior exposure to intravesical LGG®; and 9. Active cancer (or within 5 years) or active autoimmune disorder
Where this trial is running
Washington D.C., District of Columbia
- MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Suzanne Groah, MD, MSPH — MedStar National Rehabilitation Hospital
- Study coordinator: Emily Leonard, PhD
- Email: emily.m.leonard@medstar.net
- Phone: (202) 877-1844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.