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Probiotic

Probiotics for Neurogenic Bladder

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

Women must be premenopausal and not currently menstruating

Neurogenic bladder for at least 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial is testing if a specific probiotic can help reduce urinary symptoms and inflammation.

Who is the study for?

This trial is for people with neurogenic bladder for at least 6 months, using indwelling catheters. Premenopausal women not currently menstruating can join. Excluded are those on antibiotics, receiving antimicrobials to prevent UTI, unable to follow instructions due to mental health conditions, recently sexually active or in another conflicting study.Check my eligibility

What is being tested?

The trial tests intravesical Lactobacillus RhamnosusGG (LGG®) delivered directly into the bladder via a catheter. The goal is to find the best dose that reduces urinary symptoms and improves urine health without causing harm before moving on to a larger scale study.See study design

What are the potential side effects?

Potential side effects may include discomfort during instillation, changes in urinary habits or infections due to altering the balance of bacteria in the bladder ecosystem.

Eligibility Criteria

Inclusion Criteria

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

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I am a premenopausal woman not having periods.

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I have had bladder control issues due to nerve problems for at least 6 months.

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I have a physical disability and live in the community.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bacteria

Change in Urine NGAL

Change in Urine Nitrite

+7 more

Trial Design

2Treatment groups

Active Control

Group I: High dosageActive Control1 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 indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. 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.

Group II: Low DosageActive Control1 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 indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteOTHER

211 Previous Clinical Trials

207,975 Total Patients Enrolled

Medstar Health Research InstituteLead Sponsor

189 Previous Clinical Trials

115,391 Total Patients Enrolled

Suzanne Groah, MD, MSPHPrincipal InvestigatorMedStar National Rehabilitation Hospital

2 Previous Clinical Trials

302 Total Patients Enrolled

Media Library

Culturelle 10 Billion CFU Capsule (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04323735 — Phase 2

Neurogenic Bladder Research Study Groups: High dosage, Low Dosage

Neurogenic Bladder Clinical Trial 2023: Culturelle 10 Billion CFU Capsule Highlights & Side Effects. Trial Name: NCT04323735 — Phase 2

Culturelle 10 Billion CFU Capsule (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04323735 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have agreed to participate in this research project?

"The information available on clinicaltrials.gov indicates that this trial is still recruiting patients. This trial was posted on 1/10/2020, with the most recent update on 6/13/2022. So far, 182 people have enrolled at the 1 location."

Answered by AI

What is the recommended dosage of this medication?

"There is some evidence from previous trials to support the efficacy of high dosage, as well as data from multiple rounds of testing that suggest it is safe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters

2020. "Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04323735.