Vaginal Atrophy Clinical Trial
— IMPLOREOfficial title:
IMPLORE Study: Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
Verified date | April 2024 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of vaginal estrogen use. The investigators plan to characterize the composition and dynamics of the microbiomes of the vagina, bladder, and rectum for quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) before and after eight weeks of local vaginal estrogen therapy. Although the vagina, bladder, and gut microbiomes have been increasingly independently studied, less is known about the interactions of the bacterial communities among the three environments as well as the dynamic relationship with menopausal status and vaginal estrogen therapy and the investigators seek to elucidate these relationships further.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 14, 2021 |
Est. primary completion date | January 14, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - Postmenopausal with vulvovaginal atrophy - Age =55 years old and a screening vaginal pH of =5. - Without menses for =12 months. - No uterovaginal or vaginal vault prolapse beyond the hymen. - No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study) Exclusion Criteria: - Patients with BMI >35kg/m2 - Any patients with infections requiring antibiotic or antifungal therapy during the study period. - Study patients may not use any vaginal suppositories, douches, or vaginal hygiene wipes within the month preceding enrollment. For patients already on hormone therapy, will be allowed to undergo a "wash out" period of estrogen or progesterone products for one month prior to enrollment. - Additional exclusions included patients with systemic conditions requiring immunosuppressive drugs, currently receiving chemotherapy, or history of pelvic radiation. - Any patients with contraindications to vaginal estrogen therapy including: vaginal bleeding of unknown etiology; known, suspected, or history of breast cancer or estrogen-dependent neoplasia; active DVT, PE, or h/o these conditions; active arterial thromboembolic disease (ie. stroke or MI) or h/o of these; known liver disease or thrombophilic disorders. - Current tobacco use. - Allergy to Premarin® or its constituents. - Concurrent use of steroid creams for other indications (ie. lichen sclerosis) |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quantitative and Qualitative Changes in the Distribution of Operational Taxonomic Units (OTUs) in the Bladder Microbiome. | Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks. | Baseline, 8 weeks | |
Other | Quantitative and Qualitative Changes in the Distribution of Operational Taxonomic Units (OTUs) in the Rectal Microbiome. | Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks. | Baseline, 8 weeks | |
Other | Bladder Inflammatory Biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF) | Change in the concentration of bladder inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks | Baseline, 8 weeks | |
Other | Rectal Inflammatory Biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF) | Change in the concentration of rectal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks | Baseline, 8 weeks | |
Primary | Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina | The relative abundance of the Lactobacillus genus, as measured by 16S ribosomal RNA (rRNA) gene sequencing, is the proportion of Lactobacillus genus among the total vaginal microbiome. After analysis of the gene sequencing, the total yield of bacteria at the genus level equals 1.
The quantitative change in relative abundance of Lactobacillus among the community composition of bacteria in the vagina will be assessed from baseline to 8 weeks. The investigators hypothesize that a pre-specified statistically significant quantitative increase in the relative abundance of Lactobacillus will be seen among the participants that receive treatment. |
Baseline, 8 weeks | |
Secondary | Change in Vaginal Maturation Index (VMI) | The maturation value (MV) is calculated with the following formula: MV = % surface cells + (0.5 Ă— % intermediate cells).
The outcome data is reported as the delta change from baseline to 8 weeks. The data for the primary outcome has been entered using the "measure type - NUMBER" because the outcome is a delta or change in the vaginal maturation index. |
Baseline, 8 weeks | |
Secondary | Change in Vaginal pH | Change in the vaginal pH from baseline to 8 weeks | Baseline, 8 weeks | |
Secondary | Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF | Change in the vaginal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks | Baseline, 8 weeks |
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