The Effect of Red Clover Isoflavones on Urinary Microbiota Composition and Interaction With the Urothelium in Postmenopausal Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Change in baseline microbiota composition at three months follow-up
Study Overview
Brief Summary
The purpose of this study is to investigate the effect of red clover isoflavones in postmenopausal women with and without urge urinary incontinence and overactive bladder
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Postmenopausal (more than 5 years since last menstruation)
- •Read and understand Danish
Exclusion Criteria
- •Participants receive treatment with estrogen both oral, transdermal, and topical within three months prior to inclusion in the study
- •Participants take estrogen-like compounds (isoflavones) three months prior to inclusion in the study
- •Participants take prebiotic and/or probiotic supplements within three months prior to study inclusion
- •Receive antibiotics (any) within three months prior to inclusion in the study
- •Recurrent urinary tract infections (defined as ≥ 2 infections in the last six months or ≥ 3 infections during the last year)
- •Acute urinary tract infection defined as positive urine culture and symptoms of acute cystitis
- •Previous or current diseases of the digestive and/or urinary systems evaluated by PI (including, but not limited to inflammatory bowel disease (IBD) and cancer)
- •Current or prior suffering from breast, ovary, and/or endometrial cancer
- •Use hormone spiral within the last 5 years if they are under 60 years
- •Hysterectomy before cessation of menstrual periods if the women are below the age of 60
Outcomes
Primary Outcomes
Change in baseline microbiota composition at three months follow-up
Time Frame: From baseline to three months follow-up
The microbiota composition is analyzed using sequencing of bacterial DNA. Comparison of healthy women without bladder symptoms receiving RCE (healthy RCE) at baseline to three months follow-up compared to controls (healthy PL) from baseline to follow-up. Healthy RCE from baseline to follow-up vs. Healthy PL from baseline to follow-up
Difference in baseline microbiota composition between women with and without UUI and OAB
Time Frame: Baseline
The microbiota composition is analyzed using sequencing of bacterial DNA. Is there a difference in the urinary, vaginal and gut microbiota in women with and without urge urinary incontinence (UUI) and overactive bladder (OAB) at baseline? Symptomatic PL baseline vs. Healthy PL baseline
Change from baseline microbiota composition in women suffering from UUI and OAB at three months follow-up
Time Frame: From baseline to three months follow-up
The microbiota composition is analyzed using sequencing of bacterial DNA. We are investigating the urinary, vaginal and gut microbiota. In women with urge urinary incontinence (UUI) and overactive bladder (OAB) receiving RCE (symptomatic RCE), a possible change in the urinary, vaginal and fecal microbiota composition from baseline to three month follow-up, compared to controls receiving placebo (symptomatic PL) are investigated. Symptomatic RCE from baseline to follow-up vs. Symptomatic PL from baseline to follow-up
Secondary Outcomes
- Comparison of the urinary, vaginal, and fecal microbiota(Baseline)
- Change in urinary incontinence symptoms from baseline in women suffering from UUI and OAB at three months follow-up(From baseline to three months follow-up)
- Change in overactive bladder symptoms from baseline in women suffering from UUI and OAB at three months follow-up(From baseline to three months follow-up)
- Change in blood equol levels from baseline to three months follow-up(From baseline to three months follow-up)
- Change in blood estrogen levels from baseline to three months follow-up(From baseline to three months follow-up)
- Change in gastrointestinal symptoms from baseline to three months follow-up(From baseline to three months follow-up)
- Change in blood isoflavone levels from baseline to three months follow-up(From baseline to three months follow-up)
- Change in Irritable Bowel Syndrome Severity Score Scale from baseline to three months follow-up(From baseline to three months follow-up)
- Change in Gastrointestinal Symptom Rating Scale from baseline to three months follow-up(From baseline to three months follow-up)
Investigators
Annemarie Brusen Villadsen
Ph.D. student
Regionshospital Nordjylland