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NCT04373512
Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury
Phase 2 trial testing Culturelle 10 Billion CFU Capsule (2 doses) in Spinal Cord Injuries in 182 participants. Completed in 14 February 2025.
14 February 2025
Quick facts
| Lead sponsor | Medstar Health Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 182 |
| Start date | 20 May 2020 |
| Primary completion | 14 February 2025 |
| Estimated completion | 14 February 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Culturelle 10 Billion CFU Capsule (2 doses) — full drug profile →
- Culturelle 10 Billion CFU Capsule (4 doses) — full drug profile →
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
- Neurogenic Bladder — all drugs for Neurogenic Bladder →
Sponsor
Medstar Health Research Institute
Who can join
18 and older, any sex, with Spinal Cord Injuries or Neurogenic Bladder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04373512
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
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- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other Medstar Health Research Institute trials
Trials by the same sponsor.
- NCT07445932 — Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support · NA · not yet recruiting
- NCT07318545 — Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors · NA · not yet recruiting
- NCT07337642 — Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty · NA · recruiting
- NCT07228377 — Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) Study · NA · recruiting
- NCT07223489 — Diagnostic Journey, Patient Experience, and Disparities in the Treatment of Spinal Muscular Atrophy (SMA) in the MedStar · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04373512 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medstar Health Research Institute
- Last refreshed: 13 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04373512.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing