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

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Citation: Journal of Spinal Cord Medicine. 44(1):62-69, 2021 01.PMID: 31100050Institution: MedStar National Rehabilitation Network | MedStar Washington Hospital CenterDepartment: Physical Medicine and RehabilitationForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Lactobacillus rhamnosus | *Spinal Cord Injuries | *Urinary Bladder, Neurogenic | Administration, Intravesical | Adult | Child | Health Promotion | HumansYear: 2021ISSN:
  • 1079-0268
Name of journal: The journal of spinal cord medicineAbstract: 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).All authors: Caldovic L, Forster CS, Groah S, Hsieh MH, Ljungberg I, Perez-Losada M, Pohl H, Sprague B, Stroud COriginally published: Journal of Spinal Cord Medicine. :1-8, 2019 May 17Fiscal year: FY2021Fiscal year of original publication: FY2019Digital Object Identifier: Date added to catalog: 2019-06-21
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Journal Article MedStar Authors Catalog Article 31100050 Available 31100050

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).

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