- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02415868
Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women (FLORA)
Development of an Ex-vivo High-throughput Screening Assay for the Vaginal Microbiota of Post-menopausal Women
Study Overview
Status
Conditions
Detailed Description
Vaginal swabs will be collected from post-menopausal women (5 women vaginal pH ≤4.5 and 5 women with vaginal pH≥5.5), aged 45 - 75, with at least 12 months of amenorrhea. Enough women will be screened to ensure five women for each pH range.
Using a speculum, the mid lateral vaginal wall is made visible, samples will be collected by the physician or nurse using a flocked swab. After collection, vaginal swabs will be stored immediately in adequate liquid medium at 4ºC and will be transported to the lab within 7 hours after sampling for further storage and culture of the material.
The vaginal microbiota of post-menopausal women with a vaginal pH of ≤ 4.5 and ≥ 5.5 will be characterized and compared using 16S ribosomal ribonucleic acid (rRNA) sequencing. In additional, optimal conditions for cultivation and storage of the vaginal microbiota will be examined for use in assays mimicking the vaginal microbial community of postmenopausal women.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9700
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Agree to study design (signed informed consent)
- Post-menopausal women
- Vaginal pH ≤4.5 or pH ≥5.5
- At least 12 months of amenorrhea
- Age ≥45 and ≤75
- Currently in a mutually monogamous sexual relationship or not sexually active;
- Sexually abstinent 48 hours prior to visit.
- Willing and capable of following all study instructions; and
- Good general health.
Exclusion Criteria:
- Vaginal pH between >4.5 and <5.5
- Use of topical estrogen containing product 1 week prior to enrollment
- Use of vaginal lubricants, douches, or any products applied vaginally during the week prior to the first visit
- Use of systemic estrogen therapy or products 6 months prior to inclusion
- Use of a vaginal pessary during the week prior to the visit
- Excessive alcohol usage (>4 consumptions/day or >20 consumptions/week)
- Drug usage within past 2 years
- A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
- A medical condition which might compromise immune system functions (such as cancer, leucopenia, HIV-positive, or organ transplant)
- Antibiotics and/or anti-fungal medication use within the last four (4) weeks
- Induced menopause due to surgical or medical interventions, such as bilateral oophorectomy, hysterectomy, chemotherapy or radiation treatment
- Currently diagnosed with or being treated for a genital infection or urinary tract infection, subjects who had any vaginal infection one month prior to the screening will be excluded
- Individuals with a sexually transmitted disease (self-reported or detected by the Principal Investigator)
- At enrollment, have any social or medical condition, or psychiatric illness that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- Participation in a clinical trial involving an investigational product/device within the past three months; subjects who are scheduled to participate in another clinical study concurrently.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Low pH
Post Menopausal women with vaginal pH of 4.5 or below
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High pH
Post Menopausal women with vaginal pH of 5.5 or above
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Characterization of the microbiota
Time Frame: 0 hours
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By 16s rRNA sequencing
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0 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ellen Klinkert, MD, Department of Gynaecology, University Medical Center Groningen
Publications and helpful links
General Publications
- Hummelen R, Macklaim JM, Bisanz JE, Hammond JA, McMillan A, Vongsa R, Koenig D, Gloor GB, Reid G. Vaginal microbiome and epithelial gene array in post-menopausal women with moderate to severe dryness. PLoS One. 2011;6(11):e26602. doi: 10.1371/journal.pone.0026602. Epub 2011 Nov 2.
- Chaban B, Links MG, Jayaprakash TP, Wagner EC, Bourque DK, Lohn Z, Albert AY, van Schalkwyk J, Reid G, Hemmingsen SM, Hill JE, Money DM. Characterization of the vaginal microbiota of healthy Canadian women through the menstrual cycle. Microbiome. 2014 Jul 4;2:23. doi: 10.1186/2049-2618-2-23. eCollection 2014.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 500-14-0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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