Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial
NCT ID: NCT06546189
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-04-01
2027-10-01
Brief Summary
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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 (yes/no) 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
OMNi BiOTiC® 41167 sachet diluded in a glass of water twice daily oral intake for 6 months
OMNi BiOTiC® 41167
The product "OMNi BiOTiC® 41167" contains lactobacillus strains
2
Placebo sachet diluted in a glass of water twice daily oral intake for 6 months
Placebo
Placebo
Interventions
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OMNi BiOTiC® 41167
The product "OMNi BiOTiC® 41167" contains lactobacillus strains
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* neurogenic overactive bladder
18 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Marianne Koch
Priv.-Doz.Dr.med.univ., PhD
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1917/2024
Identifier Type: -
Identifier Source: org_study_id
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