Clinical trial NCT02415868: Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women
Official title: Development of an Ex-vivo High-throughput Screening Assay for the Vaginal Microbiota of Post-menopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Syndrome
Keywords: Vaginal Microbiota
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
Collaborators: name: NIZO Food Research
name: University Medical Center Groningen
First posted: 2015-04-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal women

Brief summary: This purpose of this study is to collect vaginal microbial samples of postmenopausal women to assess the optimal conditions for cultivation and storage of the vaginal microbiota. These samples will subsequently be used to develop a high-throughput assay that mimicks the vaginal microbial community of postmenopausal women. This assay will be used to select and screen compounds that can affect the vaginal microbiota and subsequently affect related symptoms such as vaginal dryness.

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.

Eligibility criteria: Inclusion Criteria:

1. Agree to study design (signed informed consent)
2. Post-menopausal women
3. Vaginal pH ≤4.5 or pH ≥5.5
4. At least 12 months of amenorrhea
5. Age ≥45 and ≤75
6. Currently in a mutually monogamous sexual relationship or not sexually active;
7. Sexually abstinent 48 hours prior to visit.
8. Willing and capable of following all study instructions; and
9. Good general health.

Exclusion Criteria:

1. Vaginal pH between \>4.5 and \<5.5
2. Use of topical estrogen containing product 1 week prior to enrollment
3. Use of vaginal lubricants, douches, or any products applied vaginally during the week prior to the first visit
4. Use of systemic estrogen therapy or products 6 months prior to inclusion
5. Use of a vaginal pessary during the week prior to the visit
6. Excessive alcohol usage (\>4 consumptions/day or \>20 consumptions/week)
7. Drug usage within past 2 years
8. A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
9. A medical condition which might compromise immune system functions (such as cancer, leucopenia, HIV-positive, or organ transplant)
10. Antibiotics and/or anti-fungal medication use within the last four (4) weeks
11. Induced menopause due to surgical or medical interventions, such as bilateral oophorectomy, hysterectomy, chemotherapy or radiation treatment
12. 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
13. Individuals with a sexually transmitted disease (self-reported or detected by the Principal Investigator)
14. 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
15. 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.

Primary outcomes:
measure: Characterization of the microbiota
timeFrame: 0 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Department of Gynaecology, University Medical Center Groningen
name: Ellen Klinkert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.