Lubricant Use and the Vaginal Microbiome
润滑剂的使用和阴道微生物组
基本信息
- 批准号:9052986
- 负责人:
- 金额:$ 79.42万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2016
- 资助国家:美国
- 起止时间:2016-02-05 至 2021-01-31
- 项目状态:已结题
- 来源:
- 关键词:AffectAnti-Bacterial AgentsAnti-Inflammatory AgentsAnti-inflammatoryAttentionBacteriaBacterial VaginosisBehavioralBiological AssayBiological MarkersCell DeathCell secretionCellsChlamydiaChlorhexidineClinicalClinical TrialsControlled StudyCosmeticsDNADataDevelopmentDoseDrynessDyspareuniaEpidemiologic StudiesEpithelialEpithelial CellsEpitheliumEvaluationFemaleFibronectinsFormulationFundingGlycerolGlycogenGynecologicHIVHumanHuman MicrobiomeImmune responseImmunologic MarkersIncidenceInfectionInflammatoryIsomerismLactate DehydrogenaseLactic acidLactobacillusLeadLubricantsMeasurementMeasuresMedical DeviceMethodsMucous body substanceObservational StudyOrganismParabensParticipantPlayPostmenopausePredispositionProceduresPropylene GlycolsProtozoaQuality of lifeRadiology SpecialtyRecording of previous eventsRecruitment ActivityReportingReproductive Tract InfectionsResearchRibosomal RNARiskRoleSafetySamplingSexually Transmitted DiseasesSkinSurfaceSurveysSwabSymptomsTimeToxic effectToxicant exposureTransvaginal UltrasoundTraumaUltrasonographyUnited States National Institutes of HealthUrinary tractUrinary tract infectionVaginaVaginal DischargeViralWomanWorkclinical practicecohortcostcytokinedesigndiariesdigitalimprovedinterestmicrobiomemicrobiotamultidisciplinarynovelpleasurepreventpublic health relevancerRNA Genesrepositoryreproductive tractresponsesafety testingself esteemsexsocialtime usevaginal lactobacillivaginal microbiome
项目摘要
DESCRIPTION (provided by applicant): Twenty-five percent of U.S. women report frequent use of vaginal lubricants to reduce discomfort and increase pleasure during sex. Clinically, lubricants are also used for digital exams and procedures such as trans-vaginal ultrasound (T-VUS). Among postmenopausal women, 50% use lubricants due to vaginal dryness and dyspareunia. The first line treatment for these women is non-hormonal vaginal lubricants. Recent studies have questioned the safety of current lubricants, yet there is little available data A healthy vagina is protected by Lactobacillus spp. that acidify the vagina with lactic acid, a potent bacteriocide and viricide. Disruption of this healthy microbiome markedly increases susceptibility to reproductive tract infections. We hypothesize that lubricants can disrupt the vaginal microbiome and increase risk to infections. Most vaginal lubricants contain hypertonic humectants such as glycerol or propylene glycol together with antibacterial preservatives, parabens and sometimes chlorhexidine. The active ingredients are "generally recognized as safe" (GRAS) by the FDA, hence are not subject to human clinical trials. However, at high concentrations or with frequent use, these ingredients may have toxic effects. It is unknown if hypertonic antibacterial lubricants affect the vaginal microbiota. We propose three aims to study the effect of lubricant on the vaginal microenvironment: 1) Evaluate the effects of lubricant on the temporal dynamics of vaginal microbiota with two methods: 1A) Perform a controlled observational study of one-time use of vaginal lubricant by recruiting women who are presenting for T-VUS, a procedure in which lubricant is applied to a T-VUS probe. This study will standardize the lubricant brand and dose by using the hypertonic lubricant currently in use by the Department of Radiology. Participants will self-collect daily samples prior to T-VUS for 1 week and twice-weekly for 9- weeks after TVUS. Changes in bacterial composition will be assessed using 16S rRNA gene analysis. 1B) Conduct a secondary analysis of existing data (behavioral diaries, clinical exams and 16S rRNA sequences) collected from a cohort of 130 women who were followed for 10 weeks in a prior study as part of the Human Microbiome Project (HMP). Participants self-collected mid-vaginal swabs daily and all samples are stored in a freezer repository. Lubricant use was reported by 37 women on 140 occasions. Samples collected every other day have already undergone DNA extraction and 16S rRNA sequencing (NIH RO1-GM103604). 2) Examine the effects of lubricant on the vaginal microenvironment in samples obtained from Aims 1A and 1B by assessing pH, D- and L-isomers of lactic acid and inflammatory cytokines. 3) Determine if lubricants have toxic effects on the vaginal epithelium using measurements of cell shedding rates, glycogen (necessary for lactobacilli survival), fibronectin (a marker of epithelial disruption), and lactate dehydrogenase (a marker of cell death) in samples collected in Aim 1A. This study will contribute to the development of safer formulations for personal and clinical lubricants.
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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REBECCA M. BROTMAN其他文献
REBECCA M. BROTMAN的其他文献
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{{ truncateString('REBECCA M. BROTMAN', 18)}}的其他基金
Cervicovaginal microbiome, mucosal immunity, and pathogen factors that contribute to spontaneous clearance of Chlamydia trachomatis
宫颈阴道微生物群、粘膜免疫和有助于沙眼衣原体自发清除的病原体因素
- 批准号:
10463072 - 财政年份:2022
- 资助金额:
$ 79.42万 - 项目类别:
Cervicovaginal microbiome, mucosal immunity, and pathogen factors that contribute to spontaneous clearance of Chlamydia trachomatis
宫颈阴道微生物群、粘膜免疫和有助于沙眼衣原体自发清除的病原体因素
- 批准号:
10631994 - 财政年份:2022
- 资助金额:
$ 79.42万 - 项目类别:
Methods to Test the Role of Age-related Lifestyle and Vaginal Microenvironment Changes and the Prevention, Treatment, and Progression of Genitourinary Syndrome of Menopause
测试与年龄相关的生活方式和阴道微环境变化以及更年期泌尿生殖综合征的预防、治疗和进展的作用的方法
- 批准号:
10475571 - 财政年份:2021
- 资助金额:
$ 79.42万 - 项目类别:
Methods to Test the Role of Age-related Lifestyle and Vaginal Microenvironment Changes and the Prevention, Treatment, and Progression of Genitourinary Syndrome of Menopause
测试与年龄相关的生活方式和阴道微环境变化以及更年期泌尿生殖综合征的预防、治疗和进展的作用的方法
- 批准号:
10675518 - 财政年份:2021
- 资助金额:
$ 79.42万 - 项目类别:
Methods to Test the Role of Age-related Lifestyle and Vaginal Microenvironment Changes and the Prevention, Treatment, and Progression of Genitourinary Syndrome of Menopause
测试与年龄相关的生活方式和阴道微环境变化以及更年期泌尿生殖综合征的预防、治疗和进展的作用的方法
- 批准号:
10091738 - 财政年份:2021
- 资助金额:
$ 79.42万 - 项目类别:
Methods to Test Lifestyle, Vaginal Microenvironment, and Genitourinary Symptoms across Menopause Transition
测试更年期过渡期间生活方式、阴道微环境和泌尿生殖系统症状的方法
- 批准号:
10229293 - 财政年份:2020
- 资助金额:
$ 79.42万 - 项目类别:
Longitudinal Study of the Vaginal Microbiome Prior To Incident STI
性传播感染发生前阴道微生物组的纵向研究
- 批准号:
8963646 - 财政年份:2015
- 资助金额:
$ 79.42万 - 项目类别:
Vaginal microbiota, immune responses and vulvovaginal symptoms during menopause
更年期期间的阴道微生物群、免疫反应和外阴阴道症状
- 批准号:
8721849 - 财政年份:2013
- 资助金额:
$ 79.42万 - 项目类别:
Vaginal microbiota, immune responses and vulvovaginal symptoms during menopause
更年期期间的阴道微生物群、免疫反应和外阴阴道症状
- 批准号:
8568384 - 财政年份:2013
- 资助金额:
$ 79.42万 - 项目类别:
Molecular Epidemiology of the Vaginal Microbiome
阴道微生物组的分子流行病学
- 批准号:
8042549 - 财政年份:2010
- 资助金额:
$ 79.42万 - 项目类别:
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