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

NCT02415868 | Completed

• 1 other identifier: 500-14-0004
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Syndrome

Keywords

Vaginal Microbiota

Outcome Measures

Primary Outcomes (1)

• Characterization of the microbiota

  By 16s rRNA sequencing

  0 hours

Study Arms (2)

Low pH

Post Menopausal women with vaginal pH of 4.5 or below

High pH

Post Menopausal women with vaginal pH of 5.5 or above

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-menopausal women

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Kimberly-Clark Corporation: lead
• NIZO Food Research: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700, Netherlands

Location

Related 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.

  PMID: 25053998 BACKGROUND

• 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.

  PMID: 22073175 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiota from Vaginal Swab

Study Officials

• Ellen Klinkert, MD

  Department of Gynaecology, University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 14, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)