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Lactobacillus Rhamnosus GG · 1 trial · 6 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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). |
| 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. |
Inclusion Criteria: * 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) Exclusion Criteria: * Known gen...
Lactobacillus Rhamnosus GG is an investigational small molecule being developed for spinal cord injury, specifically targeting neurogenic lower urinary tract dysfunction and urinary tract infections in patients with spinal cord injury. It is currently in early Phase 1 clinical development and has not been approved by the FDA.
Lactobacillus Rhamnosus GG is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with spinal cord injury.
Lactobacillus Rhamnosus GG is in Phase 1 clinical development. The drug is currently being evaluated in an early Phase 1 trial, which has not yet begun recruiting participants. It remains an investigational agent and has not received FDA approval for any indication.
Lactobacillus Rhamnosus GG is being studied in one clinical trial with the identifier NCT07643974. This early Phase 1 trial, titled 'Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD,' is a controlled, randomized study with an estimated enrollment of 48 participants. The trial is not yet recruiting and is being conducted in the United States.
Lactobacillus Rhamnosus GG is being studied in combination with gentamicin in the clinical trial NCT07643974, which is titled 'Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD.' The trial evaluates the coupled therapy for neurogenic lower urinary tract dysfunction and urinary tract infections in patients with spinal cord injury.