Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women

Postmenopausal Syndrome Clinical Trial

— FLORA  

Official title:

Development of an Ex-vivo High-throughput Screening Assay for the Vaginal Microbiota of Post-menopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415868
• Other study ID #: 500-14-0004
• Status: Completed
• Phase: N/A
• First received: April 9, 2015
• Last updated: February 22, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Kimberly-Clark Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Postmenopausal Syndrome

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (3)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation	NIZO Food Research, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the microbiota	By 16s rRNA sequencing	0 hours	No