Probiotics for Urinary Symptoms After Spinal Cord Injury

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of the probiotic treatment, Lactobacillus Rhamnosus GG (LGG®), for reducing urinary symptoms in individuals with spinal cord injuries. Researchers seek to understand how this probiotic might alter urinary symptoms and the bacteria in urine. Participants will be divided into two groups to test different doses of the treatment. This trial is suitable for individuals who have had a spinal cord injury for at least one year, manage their bladder with intermittent catheterization, and are not currently using antibiotics. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications, like antibiotics, as the trial excludes those who have used oral or IV antibiotics in the past 2 weeks or are using prophylactic antibiotics. The protocol does not specify other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that Lactobacillus rhamnosus GG (LGG®), the probiotic in this trial, is safe and well tolerated. In earlier studies, placing one or two doses of this probiotic directly into the bladder did not cause any serious side effects in adults. Participants found the treatment comfortable and easy to handle.

Additionally, using LGG® aims to manage urinary symptoms without antibiotics. Other research supports this approach, suggesting it can improve urine health and reduce harmful bacteria.

For those considering joining this trial, past studies have found the treatment to be safe with minimal side effects, supporting its continued study in ongoing research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about this treatment because it uses probiotics, specifically the LGG® strain found in Culturelle capsules, to manage urinary symptoms after spinal cord injury. Unlike typical treatments that may involve antibiotics or catheter management, this approach leverages the natural benefits of probiotics to potentially reduce urinary symptoms by promoting a healthy balance of bacteria in the urinary tract. This novel method stands out due to its unique delivery through an intermittent catheter, offering a potentially gentler and more natural alternative to current options.

What evidence suggests that this treatment might be an effective treatment for urinary symptoms after spinal cord injury?

Research has shown that the probiotic Lactobacillus rhamnosus GG (LGG®) may help with urinary problems in people with spinal cord injuries. In this trial, participants will join either a low dosage group or a high dosage group to evaluate LGG's effectiveness. Studies have found that LGG can lessen symptoms like cloudy or bad-smelling urine. Past trials have demonstrated that this treatment is safe and well-tolerated. Additionally, LGG can improve the balance of bacteria in the urine, which is important for urinary health. Overall, these findings suggest that LGG could effectively manage urinary symptoms for those with spinal cord injuries. ^{1 2 3 5 6}

Who Is on the Research Team?

Suzanne Groah, MD,MSPH

Principal Investigator

MedStar National Rehabilitation Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6777056/

Intravesical Lactobacillus rhamnosus GG is safe and well ... One or two doses of self-instilled intravesical LGG® in response to more cloudy or foul-smelling urine was safe and well tolerated among this sample of adults ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02748317

Impact of Probiotics on Urinary Symptoms in Spinal Cord ... After 6 months of baseline data collection, participants will receive the Lactobacillus (Culturelle GG, 20 billion live organisms for adults and 10 billion live ...

3. nature.com nature.com/articles/s41393-019-0251-y

Probiotics [LGG-BB12 or RC14-GR1] versus placebo as ... Urinary tract infections (UTIs) are common in people with spinal cord injury (SCI). UTIs are increasingly difficult to treat due to emergence of ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pmrj.12470

Effects of Intravesical Lactobacillus Rhamnosus GG on ... Self-instilled LGG seemed to improve “clinically actionable” (A) and “urine quality” (B2) symptom burden. No changes were observed for those who ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10644857/

Intravesical Lactobacillus rhamnosus GG Alters Urobiome ... To explore the effects of one to two doses of intravesical Lactobacillus rhamnosus GG (LGG) on the urobiomes of adults with spinal cord injury/disease (SCI/D) ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595718

Self-Management of Urinary Symptoms Using a Probiotic in ... Lactobacillus rhamnosus GR-1 has been shown to reverse the UPEC-induced downregulation of nuclear factor-κB, and the same strain can disrupt E coli biofilms.