NCT05230511 Intravesical LGG VS Saline Bladder Wash RCT
| NCT ID | NCT05230511 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medstar Health Research Institute |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-06-13 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2022-06-13 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
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
Contact & Investigator
Suzanne Groah, MD, MSPH
PRINCIPAL INVESTIGATOR
MedStar National Rehabilitation Hospital
Frequently Asked Questions
Who can join the NCT05230511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05230511 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05230511 currently recruiting?
Yes, NCT05230511 is actively recruiting participants. Contact the research team at emily.m.leonard@medstar.net for enrollment information.
Where is the NCT05230511 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT05230511 clinical trial?
NCT05230511 is sponsored by Medstar Health Research Institute. The principal investigator is Suzanne Groah, MD, MSPH at MedStar National Rehabilitation Hospital. The trial plans to enroll 120 participants.