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Probiotic

Probiotic vs Saline Wash for Preventing UTIs in Neurogenic Bladders

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

Utilizing intermittent catheterization for bladder management

Age ≥18 years

Must not have

Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.)

Use of prophylactic antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at final usqnb-ic completion (between 13 to 18 months) or at participant drop-out

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a new self-management intervention to prevent UTI to usual care.

Who is the study for?

This trial is for adults over 18 with spinal cord injury (SCI) for at least 6 months, who manage their bladder using intermittent catheterization and live outside of acute care settings. It's not open to those with other genitourinary issues, current antibiotic use, recent intravesical treatments or oral antibiotics, immune deficiencies, certain psychological conditions, participation in conflicting studies, recent LGG® exposure or active cancer/autoimmune diseases.

What is being tested?

The study tests a new way to prevent urinary tract infections without antibiotics in people with neurogenic bladders due to SCI. Participants will either receive an innovative treatment called Lactobacillus Rhamnosus GG directly into the bladder or a standard saline wash as a comparison.

What are the potential side effects?

Potential side effects may include discomfort during the bladder instillation process and possible mild urinary symptoms related to the introduction of substances into the bladder. However, since this is an antibiotic-sparing approach using probiotics or saline washes, severe side effects are less likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use a catheter sometimes to help empty my bladder.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bladder or kidney condition, not including neuropathic bladder.

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I am taking antibiotics to prevent infections.

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I have received bladder treatments like gentamycin or saline.

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I have a weakened immune system.

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I have had cancer or an autoimmune disorder in the last 5 years.

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I have not taken any oral antibiotics in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at final usqnb-ic completion (between 13 to 18 months) or at participant drop-out

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at final usqnb-ic completion (between 13 to 18 months) or at participant drop-out

This trial's timeline: 3 weeks for screening, Varies for treatment, and at final usqnb-ic completion (between 13 to 18 months) or at participant drop-out for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

International SCI Core Data Set

International SCI Lower Urinary Tract Function Basic Data Set

NINDS Medical History CDE

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)Experimental Treatment1 Intervention

LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, 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 after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months.

Group II: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase)Experimental Treatment1 Intervention

LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, 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 after the last catheterization prior to going to bed. They will then instill the LGG® mixture every 2 days for the remainder of the 6 months. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months.

Group III: Intravesical Bladder Wash (Treatment Phase)Experimental Treatment1 Intervention

Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months.

Group IV: Intravesical Bladder Wash (Prophylaxis Phase)Experimental Treatment1 Intervention

Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. They will then instill the saline BW every 2 days for the remainder of the 6 months. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months.

0 / 8Eligibility criteria met