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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

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ (sa2) 24-48 hours after intervention completion

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met