A Randomized, Double-Blind, Placebo-Controlled Trial of An Orally-Administered Vaginal Probiotic for Validation of Patient-Reported Vaginal Odor Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Vaginal odor frequency
研究概览
简要总结
This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms. Eligibility is determined by the presence of vaginal symptoms. Participation in the trial lasts approximately 75 days; during 15 of these days, participants consume a capsule containing the active form of the probiotic or a placebo. Participants complete weekly questionnaires with items pertaining to their subjective vaginal health as well as a daily diary during participation.
详细描述
This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms on women who experience vaginal odor and are otherwise healthy. Eligibility is determined by the presence of vaginal symptoms. Participation in the trial lasts approximately 75 days. Preceding intervention, there is a 7-day run-in period. Participants who surpass the run-in period take a dose of the orally-administered study product (active or placebo) once daily for 15 days, which is followed by a 15-day off-treatment period. Participants complete weekly questionnaires and daily diaries with items pertaining to their subjective vaginal health during the run-in and intervention periods. Participants then enter into a 30-day washout period, ending with the completion of one final questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women who are 18-65 years of age (inclusive).
- •Have a body mass index (BMI) between 18.5 to 29.9 kg/m2 (inclusive).
- •Experiences vaginal odor.
- •Maintains study eligibility status during the run-in period (as outlined during the pre-screening period) from screening through the end of the study.
- •Have no current medical diagnosis of active bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or urinary tract infection (UTI), or any other active infectious, inflammatory, or neoplastic vulvovaginal or genitourinary disorder.
- •Have not been medically diagnosed with recurrent BV as defined by 3 or more diagnosed infections in the past 12 months, recurrent VVC as defined by 3 or more symptomatic, diagnosed infections in the past 12 months, or recurrent UTIs as defined by 3 or more diagnosed infections in the past year or 2 or more diagnosed infections in the past 6 months.
- •In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
- •Willing to report information related to your menstrual cycle and menopause status.
- •Agree to refrain from using probiotic/prebiotic supplements (oral or vaginal); boric acid; pH-balancing tampons, pads, wipes, and washes; antifungals (oral or vaginal); antibiotics, and other treatments listed in Section 6.5 during the defined timeframe.
- •Agree to refrain from making changes to current level of consumption of foods containing probiotics/prebiotics.
- •Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
排除标准
- •Active infectious, inflammatory, or neoplastic vulvovaginal or genitourinary disorder (such as vulvovaginal candidiasis, bacterial vaginosis, urinary tract infection, vulvar intraepithelial neoplasia, or lichen sclerosis).
- •Symptomatic sexually transmitted infection.
- •Use of probiotics within the past 3 months.
- •Any prior use of intervention product.
- •Use of antibiotics within the past 3 months.
- •Vaginal hormone therapy (unless dosage and modality has been stable for 90 days prior to enrollment).
- •Current use of any medications, supplements, or over-the-counter remedies (including boric acid and deodorants) for vaginal odor.
- •Vaginal rinses, moisturizers, cooling devices, cooling mattresses, or cooling sprays (unless habitually used for at least 90 days prior to enrollment).
- •Self-reported urinary incontinence.
- •Currently lactating, pregnant, or planning to become pregnant during the study period.
- •Known sensitivity, intolerability, or allergy to any of the study products or their ingredients.
- •Any clinically significant disease or disorder which, in the opinion of the study investigator, may place you at undue risk or harm, interfere with ability to participate, compromise the interpretability of the study data.
- •History of alcohol or substance abuse in the last 5 years.
- •History of smoking in the last 2 years.
- •Currently participating in another clinical research study on vulvovaginal health.
研究组 & 干预措施
Placebo
Capsule containing placebo
干预措施: Placebo (Dietary Supplement)
Active
Capsule containing active probiotic supplement
干预措施: Orally-administered probiotic (Dietary Supplement)
结局指标
主要结局
Vaginal odor frequency
时间窗: From Baseline to the end of Intervention Period at Week 4
Change in self-reported vaginal odor frequency across weekly timepoints and between groups during the intervention period as measured by the internally-developed 8-point Vaginal Odor Frequency Scale, where 0= 0 days (Never) and 7= 7 days (Every day).
Vaginal odor severity
时间窗: From Baseline to the end of Intervention Period at Week 4
Change in self-reported vaginal odor severity across weekly timepoints and between groups during the intervention period as measured by the internally-developed 6-point Vaginal Odor Severity Scale, where 0= Absent and 5= Very Severe.
次要结局
- Vaginal odor bothersomeness(From Baseline to the end of Intervention Period at Week 4)
- Vaginal symptoms as measured by the vulvovaginal symptoms questionnaire (VSQ)(From Baseline to Week 4 of the Intervention Period)
- Vaginal Odor Buden Index (OBI)(From Baseline to the end of Intervention Period at Week 4)
- Good vs Bad Vaginal Odor Days(Daily from Baseline to Week 4 during the Intervention Period)