MedTrace Logo

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

NCT04323735 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-10-22

No results posted yet for this study

Summary

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.

Conditions

  • Neurogenic Bladder

Interventions

DRUG

Culturelle 10 Billion CFU Capsule

LGG® (Culturelle Probiotic with Lactobacillus RhamnosusGG, shown to produce the largest amount of antibacterial substances against pathogenic bacteria) will be used. 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 or 4 LGG capsules (depending on randomization group) and will repeat this process the following day ("Low" dose) or twice daily for a total of four doses ("High" dose) according to randomization group.

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Suzanne Groah, MD, MSPH · MedStar National Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323735 on ClinicalTrials.gov