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Intravesical LGG VS Saline Bladder Wash RCT
RecruitingPhase 2
Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
What is being tested
- Lactobacillus RhamnosusGG (drug)
- Saline bladder wash (drug)
Sponsor: Medstar Health Research Institute · Participants: 120 · Started: Jun 13, 2022
Contact the study team
- Emily Leonard, PhD · Phone: (202) 877-1844
- Inger H Ljungberg, MPH · Phone: (202) 877-1694
Official record on ClinicalTrials.gov — NCT05230511
Locations in the U.S.
| District of Columbia | MedStar National Rehabilitation Hospital, Washington D.C. |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.