Comparing Lactobacillus Rhamnosus GG with saline bladder wash for preventing UTIs in spinal cord injury patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.