Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

NCT04373512 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00001124
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Neurogenic Bladder

Keywords

Intermittent Catheter

Outcome Measures

Primary Outcomes (31)

• Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter

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

  (SA1) day of urine collection

• Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter

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

  (SA1) day 1 post urine collection

• Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter

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

  (SA1) day 2 post urine collection

• Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter

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

  (SA1) day 3 post urine collection

• Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter

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

  (SA2) Weekly up to 29 months

• Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter

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

  (SA2) day 1 of intervention

• Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter

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

  (SA2) 24-48 hours after intervention completion

• Change in Urine white blood cell count

  urinalysis

  (SA1) day 1 post urine collection

• Change in Urine white blood cell count

  urinalysis

  (SA1) day 14 post urine collection

• Change in Urine white blood cell count

  urinalysis

  (SA 2) day 1 of intervention

• Change in Urine white blood cell count

  urinalysis

  (SA 2) 24-48 hours after intervention completion

• Change in Urine Nitrite

  urinalysis

  (SA1)day 1 post urine collection

• Change in Urine Nitrite

  urinalysis

  (SA1)day 14 post urine collection

• Change in Urine Nitrite

  urinalysis

  (SA 2) day 1 of intervention

• Change in Urine Nitrite

  urinalysis

  (SA 2) 24-48 hours after intervention completion

• Change in Urine NGAL

  Urine NGAL

  (SA1)day 1 post urine collection

• Change in Urine NGAL

  Urine NGAL

  (SA1)day 14 post urine collection

• Change in Urine NGAL

  Urine NGAL

  (SA 2) day 1 of intervention

• Change in Urine NGAL

  Urine NGAL

  (SA 2) 24-48 hours after intervention completion

• Change in Cultivable Bacteria

  urine culture

  (SA1)day 1 post urine collection

• Change in Cultivable Bacteria

  urine culture

  (SA1)day 14 post urine collection

• Change in Cultivable Bacteria

  urine culture

  (SA 2) day 1 of intervention

• Change in Cultivable Bacteria

  urine culture

  (SA 2) 24-48 hours after intervention completion

• Change in Urine microbiome composition

  proportion of different bacterial species

  (SA1)day 1 post urine collection

• Change in Urine microbiome composition

  proportion of different bacterial species

  (SA1)day 14 post urine collection

• Change in Urine microbiome composition

  proportion of different bacterial species

  (SA 2) day 1 of intervention

• Change in Urine microbiome composition

  proportion of different bacterial species

  (SA 2) 24-48 hours after intervention completion

• 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. Score is not associated with outcome

  Day 1

• International SCI Core Data Set

  Includes date of injury, dates of initial hospitalization admission and discharge, neurological data. Score is not associated with outcomes

  Day 1

• NINDS Medical History CDE:

  A brief medical history using body system categories. Score is not associated with outcomes

  Day 1

• 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. Score is not associated with outcomes

  Day 1

Study Arms (2)

Low Dosage Group

EXPERIMENTAL

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 intermittent catheter. 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 (2 doses)

High Dosage Group

EXPERIMENTAL

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 intermittent catheter. 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 (4 doses)

Interventions

Culturelle 10 Billion CFU Capsule (2 doses) DRUG

For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 2 LGG capsules and will repeat this process the following night ("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 capsules

Also known as: Lactobacillus RhamnosusGG

Low Dosage Group

Culturelle 10 Billion CFU Capsule (4 doses) DRUG

For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 LGG capsules and will repeat this process twice daily 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 capsules

Also known as: Lactobacillus RhamnosusGG

High Dosage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SCI at least 1-year duration;
• Neurogenic bladder;
• Utilizing intermittent catheterization for bladder management;
• Women must be premenopausal and not currently menstruating;
• Community dwelling

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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Children's National Research Institute: collaborator

Study Sites (1)

MedStar National Rehabilitation Hospital

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

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Groah, MD, MSPH

  MedStar National Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Design: Prospective, randomized pilot intervention clinical trial. Target Enrollment: 182 subjects total at least 1-year post-SCI. 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.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: May 4, 2020
• Study Start: May 20, 2020
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)