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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I use a catheter sometimes to help empty my bladder.
Select...
I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
International SCI Core Data Set
International SCI Lower Urinary Tract Function Basic Data Set
NINDS Medical History CDE
+3 moreTrial 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.
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Who is running the clinical trial?
Medstar Health Research InstituteLead Sponsor
189 Previous Clinical Trials
115,453 Total Patients Enrolled
Suzanne Groah, MD, MSPHPrincipal InvestigatorMedStar National Rehabilitation Hospital
2 Previous Clinical Trials
364 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use a catheter sometimes to help empty my bladder.I have received bladder treatments like gentamycin or saline.I am taking antibiotics to prevent infections.I have a bladder or kidney condition, not including neuropathic bladder.You have had a spinal cord injury for at least 6 months.I live at home and not in a hospital.It has been over 6 months since my last LGG® treatment.I have a weakened immune system.I have had cancer or an autoimmune disorder in the last 5 years.I have not taken any oral antibiotics in the last 2 weeks.You have mental health conditions that make it hard to follow instructions.I am 18 years old or older.You have neurogenic lower urinary tract dysfunction, diagnosed by your spinal cord injury (SCI) doctor or urologist.
Research Study Groups:
This trial has the following groups:- Group 1: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)
- Group 2: Intravesical Bladder Wash (Treatment Phase)
- Group 3: Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase)
- Group 4: Intravesical Bladder Wash (Prophylaxis Phase)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Lactobacillus RhamnosusGG a viable option for patients?
"Lactobacillus RhamnosusGG is backed by Phase 3 clinical trial data, so it received a score of 3 for safety."
Answered by AI
How many individuals are being surveyed in this research project?
"The information available on clinicaltrials.gov indicates that this trial is currently recruiting patients. This study, which was first posted on June 13th 2022, is looking for 120 participants from 1 site."
Answered by AI
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