Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

NCT07643974 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY00009848HT94252410372
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of the proposed research study is to determine in men and women with spinal cord injury/disease and neurogenic bladder whether the dose of coupled gentamicin \& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Secondary objectives include determining whether that recolonization lasts 7, 14, or 28 days; and safety of the coupled gentamicin \& Lactobacillus instillations.

Conditions

Spinal Cord Injury; Neurogenic Bladder (NB); Neurogenic Lower Urinary Tract Dysfunction; Multiple Sclerosis; Spina Bifida; Urinary Tract Infection(UTI)

Keywords

gentamicin; gentamycin; lactobacillus; spinal cord injury; spinal cord disease; urinary tract infection; neurogenic bladder

Outcome Measures

Primary Outcomes (1)

• Level of Lactobacillus rhamnosus GG in Urine

  Urine samples will be analyzed with qPCR to determine whether LGG is present and, if so, at what concentration. Concentration from 24 hours after final LGG instillation will be compared to that measured after final gentamicin instillation. An increase of 30% or greater from baseline will be considered successful recolonization if LGG is present at baseline, otherwise absolute increase will be used.

  24 hours after final LGG instillation

Secondary Outcomes (1)

• Length of Recolonization

  28 days after final Lactobacillus instillation

Study Arms (2)

Low Dose

EXPERIMENTAL

Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization; the solution will be left indwelling until the next catheterization. This will be done six times. Low dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin. Low dose participants will do this in once in the evening and again 12 hours later (the following morning). This mixture will remain in the bladder for at least 4 hours.

Drug: Gentamicin; Drug: Lactobacillus Rhamnosus GG

High Dose

EXPERIMENTAL

Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization; the solution will be left indwelling until the next catheterization. This will be done six times. High dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin. High dose participants will do this in once in the evening, and again every 12 hours until four doses are complete. This mixture will remain in the bladder for at least 4 hours.

Drug: Gentamicin; Drug: Lactobacillus Rhamnosus GG

Interventions

Gentamicin DRUG

Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers, with the extra syringe being included in case of damage or accidental dropping of one of the six instillations. Patients will be instructed to refrigerate all syringes immediately upon receipt. The first instillation will occur after the first catheterization of the morning. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization and the solution has reach room temperature; the solution will be left indwelling for at least four hours. This will be done every 12 hours for three days (6 doses).

High Dose; Low Dose

Lactobacillus Rhamnosus GG DRUG

Participants will be instructed to mix the contents of 1 LGG capsule into 45cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60 cc syringe and instill the first dose via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 or 6 LGG capsules (2 additional capsules/participant, depending on randomization group) and will repeat this process every 12 hours until s/he has completed assigned dosing, according to randomization group. The first LGG instillation will occur 72 hours after the final dose of gentamicin.

Also known as: Lactobacillus RhamnosusGG

High Dose; Low Dose

Eligibility Criteria

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

You may qualify if:

• Neurologic diagnosis
• ≥18 years old
• Neurogenic bladder for at least 6 months
• No USQNB-IC A, B1, or B2 symptoms
• No currently diagnosed UTI (within 24 hours of initiating instillations)
• Community dwelling (not in acute hospital setting)

You may not qualify if:

• Known genitourinary pathology beyond NLUTD (i.e. kidney stones, bladder stones, vesicoureteral reflux, etc.)
• Use of prophylactic antibiotics or any antibiotics within 2 weeks of beginning instillations
• Instillation of intravesical agents other than saline bladder wash
• Immunodeficiency
• Psychologic or psychiatric conditions influencing the ability to follow instructions
• Allergy to ampicillin, daptomycin, gentamicin/gentamycin, or probiotics
• Participation in another study which could confound results

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• United States Department of Defense: collaborator
• University of Pittsburgh Medical Center: collaborator

Study Sites (2)

MedStar National Rehabilitation Hospital

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

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Multiple Sclerosis; Spinal Dysraphism; Urinary Tract Infections; Spinal Cord Diseases

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

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; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Amanda Garver, DO

  MedStar National Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher R Riegner, MPH

CONTACT

202-877-1000; christopher.r.riegner@medstar.net

Inger H Ljungberg, MPH

CONTACT

202-877-1000; inger.h.ljungberg@medstar.net

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Design: prospective, randomized pilot clinical trial. Target Enrollment: 48 subject total at least 6 months post SCI. Setting: Washington, DC metropolitan area (DC, MD, \& VA) and Pittsburgh area (PA). Controls: each participant will serve as their own control.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-05

Locations

US (2)