A single intravesical instillation of Lactobacillus rhamnosus GG is safe in children and adults with neuropathic bladder: A phase Ia clinical trial

The Journal of Spinal Cord Medicine, 2021 · DOI: 10.1080/10790268.2019.1616456 · Published: May 24, 2019

Urology Gastroenterology Nutrition & Dietetics

Simple Explanation

This study investigates the safety of introducing a specific type of probiotic, Lactobacillus rhamnosus GG, directly into the bladder of patients with neuropathic bladder. Neuropathic bladder is a condition where bladder function is affected by nerve damage, often leading to recurrent urinary tract infections (UTIs). The goal was to see if this method of probiotic delivery, called intravesical instillation, is well-tolerated and doesn't cause adverse effects in both children and adults.

Study Duration

Not specified

Participants

10 patients: 5 children with spina bifida and 5 adults with spinal cord injury

Evidence Level

Phase Ia safety study

Key Findings

1
Intravesical instillation of Lactobacillus rhamnosus GG was well-tolerated by all patients, with no immediate adverse events.
2
There was a significant difference in beta diversity (inter-sample) of the combined (i.e. both pre- and post-instillation) urinary microbiomes in children versus adults.
3
A single instillation of L. rhamnosus GG was associated with a microbiome shift, allowing for the growth of other acid-producing bacteria.

Research Summary

This phase Ia clinical trial assessed the safety and tolerability of a single intravesical instillation of Lactobacillus rhamnosus GG in patients with neuropathic bladder. The study included five children with spina bifida and five adults with spinal cord injury. Participants self-monitored symptoms, and urine samples were analyzed before and after the instillation. The results indicated that the probiotic instillation was well-tolerated, with no significant adverse events reported. This suggests that intravesical administration of Lactobacillus may be a safe route for UTI prophylaxis.

Practical Implications

UTI Prophylaxis

Intravesical administration of Lactobacillus could be a viable method for preventing urinary tract infections, especially in individuals with neuropathic bladder.

Microbiome Modulation

The study highlights the potential of using probiotics to modulate the urinary microbiome and correct dysbiosis, although further research is needed.

Future Research

A larger trial has been initiated to evaluate the safety, tolerability, efficacy and usability of a self-management protocol for pre-infectious urinary symptoms using instilled intravesical Lactobacillus.

Study Limitations

1
Small number of patients
2
Different etiologies of neuropathic bladder in the adults and children
3
Inability to verify the specific bacterial strains of Lactobacillus post-instillation

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