Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

PHASE2CompletedINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

May 20, 2020

Primary Completion Date

February 14, 2025

Study Completion Date

February 14, 2025

Conditions
Spinal Cord InjuriesNeurogenic Bladder
Interventions
DRUG

Culturelle 10 Billion CFU Capsule (2 doses)

"For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 2 LGG capsules and will repeat this process the following night (Low dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules"

DRUG

Culturelle 10 Billion CFU Capsule (4 doses)

"For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 LGG capsules and will repeat this process twice daily for a total of four doses (High dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules"

Trial Locations (1)

20010

MedStar National Rehabilitation Hospital, Washington D.C.

All Listed Sponsors
collaborator

Children's National Research Institute

OTHER

lead

Medstar Health Research Institute

OTHER