A single intravesical instillation of Lactobacillus rhamnosus GG is safe in children and adults with neuropathic bladder: A phase Ia clinical trial.
A single intravesical instillation of Lactobacillus rhamnosus GG is safe in children and adults with neuropathic bladder: A phase Ia clinical trial.
- 2021
CONCLUSION: Intravesical instillation of Culturelle probiotic may be safe and well-tolerated in patients with neuropathic bladder. CONTEXT/OBJECTIVE: Manipulation of the microbiome is an emerging approach to promote health. We conducted a Phase Ia safety study of a single bladder instillation of probiotics in asymptomatic patients with neuropathic bladder to determine the tolerability and safety of a single Lactobacillus instillation. DESIGN: Phase Ia safety study. INTERVENTIONS: A single Lactobacillus rhamnosus GG (Culturelle, 20 billion live organisms) instillation. OUTCOME MEASURES: After the instillation, participants self-monitored symptoms using the Urinary Symptoms Questionnaire for People with Neuropathic Bladder using Intermittent Catheterization daily for one week. Repeat urinalysis, urine culture, and 16S bacterial rRNA-based microbiome analyses were performed 7-10 days after instillation. PARTICIPANTS: Ten patients with neuropathic bladder were included: five children with spina bifida and five adults with spinal cord injury. RESULTS: Probiotic instillation was well-tolerated. One child had upper respiratory tract symptoms during the trial, and two had transient cloudy urine. No adults reported any symptoms following instillation. Lactobacillus did not grow on culture post-instillation. There were differences in beta diversity of the urine microbiome in children vs. adults with neuropathic bladder (P < 0.0156). Lactobacillus was present in the pre-instillation urinary microbiomes all of the adults and 4 out of 5 of the pediatric subjects, and identified in 4 out of 5 of both the adult and pediatric subjects' post-instillation urinary microbiomes. SETTING: Outpatient rehabilitation clinic at a rehabilitation hospital (adults) and urology clinic at a free-standing children's hospital (children).
English
1079-0268
*Lactobacillus rhamnosus
*Spinal Cord Injuries
*Urinary Bladder, Neurogenic
Administration, Intravesical
Adult
Child
Health Promotion
Humans
MedStar National Rehabilitation Network
MedStar Washington Hospital Center
Physical Medicine and Rehabilitation
Journal Article
CONCLUSION: Intravesical instillation of Culturelle probiotic may be safe and well-tolerated in patients with neuropathic bladder. CONTEXT/OBJECTIVE: Manipulation of the microbiome is an emerging approach to promote health. We conducted a Phase Ia safety study of a single bladder instillation of probiotics in asymptomatic patients with neuropathic bladder to determine the tolerability and safety of a single Lactobacillus instillation. DESIGN: Phase Ia safety study. INTERVENTIONS: A single Lactobacillus rhamnosus GG (Culturelle, 20 billion live organisms) instillation. OUTCOME MEASURES: After the instillation, participants self-monitored symptoms using the Urinary Symptoms Questionnaire for People with Neuropathic Bladder using Intermittent Catheterization daily for one week. Repeat urinalysis, urine culture, and 16S bacterial rRNA-based microbiome analyses were performed 7-10 days after instillation. PARTICIPANTS: Ten patients with neuropathic bladder were included: five children with spina bifida and five adults with spinal cord injury. RESULTS: Probiotic instillation was well-tolerated. One child had upper respiratory tract symptoms during the trial, and two had transient cloudy urine. No adults reported any symptoms following instillation. Lactobacillus did not grow on culture post-instillation. There were differences in beta diversity of the urine microbiome in children vs. adults with neuropathic bladder (P < 0.0156). Lactobacillus was present in the pre-instillation urinary microbiomes all of the adults and 4 out of 5 of the pediatric subjects, and identified in 4 out of 5 of both the adult and pediatric subjects' post-instillation urinary microbiomes. SETTING: Outpatient rehabilitation clinic at a rehabilitation hospital (adults) and urology clinic at a free-standing children's hospital (children).
English
1079-0268
*Lactobacillus rhamnosus
*Spinal Cord Injuries
*Urinary Bladder, Neurogenic
Administration, Intravesical
Adult
Child
Health Promotion
Humans
MedStar National Rehabilitation Network
MedStar Washington Hospital Center
Physical Medicine and Rehabilitation
Journal Article