Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial

NCT ID: NCT06546189

Last Updated: 2025-09-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-10-01

Brief Summary

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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 (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).

Detailed Description

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Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

OMNi BiOTiC® 41167 sachet diluded in a glass of water twice daily oral intake for 6 months

Group Type ACTIVE_COMPARATOR

OMNi BiOTiC® 41167

Intervention Type DIETARY_SUPPLEMENT

The product "OMNi BiOTiC® 41167" contains lactobacillus strains

2

Placebo sachet diluted in a glass of water twice daily oral intake for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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OMNi BiOTiC® 41167

The product "OMNi BiOTiC® 41167" contains lactobacillus strains

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of overactive bladder syndrome or mixed urinary incontinence with predominance of overactive bladder symptoms

Exclusion Criteria

* under age 18
* neurogenic overactive bladder
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Marianne Koch

Priv.-Doz.Dr.med.univ., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Marianne Koch

Role: CONTACT

+4314040029150

Facility Contacts

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Marianne Koch, PD MD PhD

Role: primary

+43 1 4040029150

Barbara Bodner-Adler, Prof. MD

Role: backup

+43 1 40400 29150

Other Identifiers

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1917/2024

Identifier Type: -

Identifier Source: org_study_id

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