Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546189
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome A Randomised Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome A Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Overactive bladder describes a syndrome characterized by frequent urges to urinate and increased urination with or without nocturia and with or without urinary incontinence Overactive bladder affects approximately 13 of older women and thus represents a condition with high prevalence Affected women report significant limitations in daily life as well as social isolation Despite the high occurrence of this condition therapeutic options are limited partly because the etiology of this condition is not fully understood Increasingly studies suggest an imbalance in the urogenital microbiome as a possible cause of the development of the condition Therefore the aim of this study is to test whether the oral administration of a lactobacillus preparation can lead to a reduction in symptoms
Design Randomized controlled study
Methods Intake of OMNi BiOTiC 41167 or placebo twice daily for 6 months swabs vaginal and urethral and urine samples from a single-use catheter for microbiome determination at 0 3 and 7 months
Outcome Reduction of subjective symptoms yesno after 3 and 7 months reduction of Overactive Bladder Symptom Score after 3 and 7 months change in the urogenital microbiome after 3 and 7 months comparison of intervention vs placebo
Design Randomized controlled study
Methods Intake of OMNi BiOTiC 41167 or placebo twice daily for 6 months swabs vaginal and urethral and urine samples from a single-use catheter for microbiome determination at 0 3 and 7 months
Outcome Reduction of subjective symptoms yesno after 3 and 7 months reduction of Overactive Bladder Symptom Score after 3 and 7 months change in the urogenital microbiome after 3 and 7 months comparison of intervention vs placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None