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Probiotic

Probiotics for Urinary Symptoms After Spinal Cord Injury

Phase 2
Recruiting
Led By Suzanne Groah, MD, MSPH
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Neurogenic bladder
Utilizing intermittent catheterization for bladder management
Must not have
Use of prophylactic antibiotics
Instillation of intravesical antimicrobials to prevent UTI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up (sa2) 24-48 hours after intervention completion
Awards & highlights

Summary

This trial will help determine how effective a certain probiotic is in reducing urinary symptoms.

Who is the study for?
This trial is for premenopausal women not currently menstruating, with spinal cord injury (SCI) for at least a year, who have neurogenic bladder and use intermittent catheterization. They should live in the community and not be part of another study or have used antibiotics recently.
What is being tested?
The trial tests two doses of Culturelle capsules to see which one might reduce urinary symptoms after SCI. It aims to understand what changes mean better health regarding urinary issues, inflammation, bacteria presence, and overall urine ecosystem.
What are the potential side effects?
While specific side effects are not listed here, Lactobacillus treatments like Culturelle can sometimes cause digestive discomfort or mild infections due to bacterial imbalance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a condition where my bladder doesn't empty properly due to nerve problems.
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I use a catheter sometimes to help empty my bladder.
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I am a premenopausal woman not having periods.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking antibiotics to prevent infections.
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I have received bladder treatments to prevent urinary infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~(sa2) 24-48 hours after intervention completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and (sa2) 24-48 hours after intervention completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Cultivable Bacteria
Change in Urine NGAL
Change in Urine Nitrite
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Dosage GroupExperimental Treatment1 Intervention
For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the intermitent catheter. Participants will receive 2 LGG capsules and will repeat this process the following day ("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 kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion.
Group II: High Dosage GroupExperimental Treatment1 Intervention
For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the intermittent catheter. Participants will receive 4 LGG capsules and will repeat this process the following day twice 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 kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion.

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
193 Previous Clinical Trials
118,052 Total Patients Enrolled
Children's National Research InstituteOTHER
218 Previous Clinical Trials
257,728 Total Patients Enrolled
Suzanne Groah, MD, MSPHPrincipal InvestigatorMedStar National Rehabilitation Hospital
2 Previous Clinical Trials
302 Total Patients Enrolled
~22 spots leftby May 2025
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