search
Back to results

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

Primary Purpose

Neurogenic Bladder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Culturelle 10 Billion CFU Capsule
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurogenic Bladder focused on measuring Indwelling catheter, Foley catheter, Suprapubic Catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • MedStar National Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low Dosage

High dosage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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
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)
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
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
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
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
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)
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
NINDS Medical History CDE:
A brief medical history using body system categories
Medical History Form
Medical history of participant
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.
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

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
November 10, 2022
Sponsor
Medstar Health Research Institute
Collaborators
Children's National Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04323735
Brief Title
Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
Official Title
Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Children's National Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for people with spinal cord injury (SCI) and neurogenic bladder (NB), it is the most common infection, secondary condition, cause for emergency room visits, and infectious cause of hospitalization. Despite its prevalence, attempts to ameliorate UTI among people with SCI are stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and specificity for UTI in this population. A high prevalence of chronic inflammation leading to persistence of white blood cells (WBC) in the urine confounds the utility of WBC count, pyuria, and leukocyte esterase as biomarkers for UTI; nitrites in urine indicate the presence of only specific (but not all) organisms, many of which are present to a greater extent in the urine of people with SCI; and people with SCI have a high prevalence of asymptomatic bacteriuria. These physiologic changes render the gold standard diagnostic tests less useful for identifying UTI in persons with SCI. SA1. Estimate healthy, asymptomatic state variability of urine NGAL (uNGAL), white blood cells (uWBC), nitrite, cultivable bacteria, and the urinary microbiome. SA2. Estimate the effect of intravesical LGG dose on urinary symptoms (primary outcome), uNGAL, uWBC, nitrites, cultivable bacteria, and the urine microbiome (secondary outcomes).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder
Keywords
Indwelling catheter, Foley catheter, Suprapubic Catheter

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dosage
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High dosage
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Culturelle 10 Billion CFU Capsule
Other Intervention Name(s)
Lactobacillus Rhamnosus GG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Time Frame
(SA 1) day of urine collection
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Time Frame
(SA 1) day 1 post urine collection
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Time Frame
(SA 1) day 2 post urine collection
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Time Frame
(SA 1) day 3 post urine collection
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Time Frame
(SA 2) Weekly up to 29 months
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Time Frame
(SA 2) day 1 of intervention (low or high dose)
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Time Frame
(SA 2) day 2 of intervention (low or high dose)
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Time Frame
(SA 2) day 3 of intervention (low or high dose)
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Time Frame
(SA 2) day 4 of intervention (low or high dose)
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Time Frame
(SA 2) day 5 of intervention (high dose only)
Title
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Description
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Time Frame
(SA 2) 24-48 hours after intervention completion
Title
Change in Urine white blood cell count
Description
urinalysis. (local urine collection participants only)
Time Frame
(SA 1) day 1 post urine collection
Title
Change in Urine white blood cell count
Description
urinalysis. (local urine collection participants only)
Time Frame
(SA 1) day 14 post urine collection
Title
Change in Urine white blood cell count
Description
urinalysis. (local urine collection participants only)
Time Frame
(SA 2) day 1 of intervention
Title
Change in Urine white blood cell count
Description
urinalysis. (local urine collection participants only)
Time Frame
(SA 2) 24-48 hours after intervention completion
Title
Change in Urine Nitrite
Description
urinalysis. (local urine collection participants only)
Time Frame
(SA 1) day 1 post urine collection
Title
Change in Urine Nitrite
Description
urinalysis. (local urine collection participants only)
Time Frame
(SA 1) day 14 post urine collection
Title
Change in Urine Nitrite
Description
urinalysis. (local urine collection participants only)
Time Frame
(SA 2) day 1 of intervention
Title
Change in Urine Nitrite
Description
urinalysis. (local urine collection participants only)
Time Frame
(SA 2) 24-48 hours after intervention completion
Title
Change in Urine NGAL
Description
Urine NGAL. (local urine collection participants only)
Time Frame
(SA 1) day 1 post urine collection
Title
Change in Urine NGAL
Description
Urine NGAL. (local urine collection participants only)
Time Frame
(SA 1) day 14 post urine collection
Title
Change in Urine NGAL
Description
Urine NGAL. (local urine collection participants only)
Time Frame
(SA 2) day 1 of intervention
Title
Change in Urine NGAL
Description
Urine NGAL. (local urine collection participants only)
Time Frame
(SA 2) 24-48 hours after intervention completion
Title
Change in Cultivable Bacteria
Description
urine culture. (local urine collection participants only)
Time Frame
(SA 1) day 1 post urine collection
Title
Change in Cultivable Bacteria
Description
urine culture. (local urine collection participants only)
Time Frame
(SA 1) day 14 post urine collection
Title
Change in Cultivable Bacteria
Description
urine culture. (local urine collection participants only)
Time Frame
(SA 2) day 1 of intervention
Title
Change in Cultivable Bacteria
Description
urine culture. (local urine collection participants only)
Time Frame
(SA 2) 24-48 hours after intervention completion
Title
Change in Urine microbiome composition and function
Description
Next generation sequencing for microbiome composition. (local urine collection participants only)
Time Frame
(SA 1) day 1 post urine collection
Title
Change in Urine microbiome composition and function
Description
Next generation sequencing for microbiome composition. (local urine collection participants only)
Time Frame
(SA 1) day 14 post urine collection
Title
Change in Urine microbiome composition and function
Description
Next generation sequencing for microbiome composition. (local urine collection participants only)
Time Frame
(SA 2) day 1 of intervention
Title
Change in Urine microbiome composition and function
Description
Next generation sequencing for microbiome composition. (local urine collection participants only)
Time Frame
(SA 2) 24-48 hours after intervention completion
Title
NINDS Medical History CDE:
Description
A brief medical history using body system categories
Time Frame
Baseline
Title
Medical History Form
Description
Medical history of participant
Time Frame
Baseline
Title
International SCI Lower Urinary Tract Function Basic Data Set
Description
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.
Time Frame
Baseline
Title
NINDS Prior and Concomitant Medications CDE
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda K Rounds, PhD
Phone
202-877-1591
Email
Amanda.K.Rounds@medstar.net
First Name & Middle Initial & Last Name or Official Title & Degree
Inger H Ljungberg
Phone
202-877-1694
Email
Inger.H.Ljungberg@medstar.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Groah, MD, MSPH
Organizational Affiliation
MedStar National Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Rounds, PhD
Phone
202-877-1591
Email
amanda.k.rounds@medstar.net
First Name & Middle Initial & Last Name & Degree
Inger Ljungberg, MPH
Phone
202 877-1694
Email
inger.h.ljungberg@medstar.net
First Name & Middle Initial & Last Name & Degree
Suzanne Groah, MD,MSPH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs