Probiotics for Urinary Symptoms After Spinal Cord Injury

Overseen By Inger H Ljungberg, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medstar Health Research Institute

Must not be taking: Antibiotics

Disqualifiers: Psychiatric conditions, Sexual activity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 29 months

182 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Suzanne Groah, MD,MSPH

Principal Investigator

MedStar National Rehabilitation Hospital

Eligibility Criteria

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.

Inclusion Criteria

I have a condition where my bladder doesn't empty properly due to nerve problems.

You live in your own home or in a community setting.

You have had a spinal cord injury for at least 1 year.

Exclusion Criteria

I am taking antibiotics to prevent infections.

I have received bladder treatments to prevent urinary infections.

You have had sex in the last 72 hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravesical Lactobacillus RhamnosusGG (LGG®) doses to reduce urinary symptoms

Up to 29 months

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Culturelle 10 Billion CFU Capsule

Trial Overview 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.

Participant Groups

Group I: Low Dosage Group Experimental Treatment 1 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 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 Group Experimental Treatment 1 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.

Culturelle 10 Billion CFU Capsule is already approved in United States, European Union for the following indications:

Approved in United States as Culturelle for:

• Digestive health support
• Immune system support

Approved in European Union as Lactobacillus rhamnosus GG for:

• Gastrointestinal health
• Immune system support

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+