NCT04323735

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for phase_2

Timeline
4mo left

Started Jan 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2020Sep 2026

Study Start

First participant enrolled

January 10, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

6.6 years

First QC Date

January 28, 2020

Last Update Submit

October 20, 2025

Conditions

Neurogenic Bladder

Keywords

Indwelling catheterFoley catheterSuprapubic Catheter

Outcome Measures

Primary Outcomes (35)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

    (SA 1) day of urine collection

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

    (SA 1) day 1 post urine collection

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

    (SA 1) day 2 post urine collection

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

    (SA 1) day 3 post urine collection

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

    (SA 2) Weekly up to 29 months

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

    (SA 2) day 1 of intervention (low or high dose)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

    (SA 2) day 2 of intervention (low or high dose)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

    (SA 2) day 3 of intervention (low or high dose)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

    (SA 2) day 4 of intervention (low or high dose)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

    (SA 2) day 5 of intervention (high dose only)

  • Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter

    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

    (SA 2) 24-48 hours after intervention completion

  • Change in Urine white blood cell count

    urinalysis. (local urine collection participants only)

    (SA 1) day 1 post urine collection

  • Change in Urine white blood cell count

    urinalysis. (local urine collection participants only)

    (SA 1) day 14 post urine collection

  • Change in Urine white blood cell count

    urinalysis. (local urine collection participants only)

    (SA 2) day 1 of intervention

  • Change in Urine white blood cell count

    urinalysis. (local urine collection participants only)

    (SA 2) 24-48 hours after intervention completion

  • Change in Urine Nitrite

    urinalysis. (local urine collection participants only)

    (SA 1) day 1 post urine collection

  • Change in Urine Nitrite

    urinalysis. (local urine collection participants only)

    (SA 1) day 14 post urine collection

  • Change in Urine Nitrite

    urinalysis. (local urine collection participants only)

    (SA 2) day 1 of intervention

  • Change in Urine Nitrite

    urinalysis. (local urine collection participants only)

    (SA 2) 24-48 hours after intervention completion

  • Change in Urine NGAL

    Urine NGAL. (local urine collection participants only)

    (SA 1) day 1 post urine collection

  • Change in Urine NGAL

    Urine NGAL. (local urine collection participants only)

    (SA 1) day 14 post urine collection

  • Change in Urine NGAL

    Urine NGAL. (local urine collection participants only)

    (SA 2) day 1 of intervention

  • Change in Urine NGAL

    Urine NGAL. (local urine collection participants only)

    (SA 2) 24-48 hours after intervention completion

  • Change in Cultivable Bacteria

    urine culture. (local urine collection participants only)

    (SA 1) day 1 post urine collection

  • Change in Cultivable Bacteria

    urine culture. (local urine collection participants only)

    (SA 1) day 14 post urine collection

  • Change in Cultivable Bacteria

    urine culture. (local urine collection participants only)

    (SA 2) day 1 of intervention

  • Change in Cultivable Bacteria

    urine culture. (local urine collection participants only)

    (SA 2) 24-48 hours after intervention completion

  • Change in Urine microbiome composition and function

    Next generation sequencing for microbiome composition. (local urine collection participants only)

    (SA 1) day 1 post urine collection

  • Change in Urine microbiome composition and function

    Next generation sequencing for microbiome composition. (local urine collection participants only)

    (SA 1) day 14 post urine collection

  • Change in Urine microbiome composition and function

    Next generation sequencing for microbiome composition. (local urine collection participants only)

    (SA 2) day 1 of intervention

  • Change in Urine microbiome composition and function

    Next generation sequencing for microbiome composition. (local urine collection participants only)

    (SA 2) 24-48 hours after intervention completion

  • NINDS Medical History CDE:

    A brief medical history using body system categories

    Baseline

  • Medical History Form

    Medical history of participant

    Baseline

  • International SCI Lower Urinary Tract Function Basic Data Set

    A tool to describe urinary tract impairment, awareness of need to empty the bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year.

    Baseline

  • NINDS Prior and Concomitant Medications CDE

    Contains whether or not the participant is taking a medication during the study protocol, name of medication, reason for medication, medication dose, frequency, start and end dates, and free text

    Baseline

Study Arms (2)

Low Dosage

ACTIVE COMPARATOR

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.

Drug: Culturelle 10 Billion CFU Capsule

High dosage

ACTIVE COMPARATOR

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.

Drug: Culturelle 10 Billion CFU Capsule

Interventions

Culturelle 10 Billion CFU CapsuleDRUG

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.

Also known as: Lactobacillus Rhamnosus GG
High dosageLow Dosage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neurogenic bladder for at least 6 months;
  • Utilizing indwelling catheterization for bladder management;
  • Women must be premenopausal and not currently menstruating;
  • Community dwelling
  • physical disability

You may not qualify if:

  • Use of prophylactic antibiotics;
  • Instillation of intravesical antimicrobials to prevent UTI;
  • Psychologic or psychiatric conditions influencing the ability to follow instructions;
  • Use of oral or IV antibiotics within the past 2 weeks;
  • Sexual activity within the previous 72 hours;
  • Participation in another study with which results could be confounded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne Groah, MD, MSPH

    MedStar National Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda K Rounds, PhD

CONTACT

202-877-1591Amanda.K.Rounds@medstar.net

Inger H Ljungberg

CONTACT

202-877-1694Inger.H.Ljungberg@medstar.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Design: Prospective, randomized pilot intervention clinical trial. Target Enrollment: 182 subjects with NLUTD at least 6 months and who use IDC for bladder management. Setting: National sample (N=114 intervention only, no urine collection) and local Washington, DC metropolitan area (N=68 intervention + urine collection). Controls: This is a 2-arm dose-finding pilot clinical trial, as such there is no control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

March 26, 2020

Study Start

January 10, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)