Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health

Study Overview
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Brief Summary
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The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.

Official Title
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An Open-label, Pilot Study to Assess the Effects of an Oral Probiotic Product on the Vaginal Microbial Community and on Parameters of Vaginal Health

Conditions
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Vaginal Health

Intervention / Treatment
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* Dietary Supplement: Oral probiotic product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women aged 18-50 years. Body mass index 18.5 - 34.9 kg/m2 (inclusive). Have childbearing potential [i.e. not surgically sterile or post-menopausal (greater than one year since last menses)]. Non-smoker, or ex-smoker ≥6 months. Nugent score of 4-6 or pH >4.5 Agrees to maintain current level of physical activity and dietary habits throughout the trial period. Agrees to discontinue use of probiotic supplements (oral or vaginal), as well as food supplemented with probiotics or prebiotics. Willing and able to provide written informed consent. Agrees to provide fecal samples during the trial period. Exclusion Criteria: Hypersensitivity to any ingredient in the study product. Pregnancy or planning pregnancy. Lactation or breast feeding. Irregular menstrual cycles. Use of contraceptives that contain spermicidal agents. Use of an intrauterine device (IUD). Use of hormonal therapy through cervical cap. Use of douching devices. Any major trauma or surgical event within the 3 months prior to screening. Individuals undergoing therapies to prevent any recurrent infections. Allergy to any antibiotic that may be prescribed as a rescue remedy during the study. Use of prescription drugs (other than birth control) within 1 month prior to Visit 1. Use of antibiotics within 2 months prior to Visit 1. History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin) Presence of systemic diseases or immunodeficiencies Abdominal or gastrointestinal surgery within the previous 12 months. Recent gastrointestinal food-borne illness (within 1 month prior to Visit 1) History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years Abnormal laboratory test results of clinical significance Presence or history (past 6 months) of alcohol or drug abuse Subject is unwilling or unable to abide by the requirements of the protocol Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral probiotic product<br> | Dietary Supplement: Oral probiotic product<br>* Once per day (QD), 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vaginal microbial community, via next generation sequencing. |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vaginal microbial community, via next generation sequencing. |  | Day 14 and 42 | 
| Changes in vaginal pH. |  | Day 14, 28 and 42 | 
| Changes in Nugent Score (Scale of 0 to 10). |  | Day 14, 28 and 42 | 
| Parameters of well-being, via Vulvovaginal Symptom Questionnaire. |  | Day 14, 28 and 42 | 
| Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events. |  | Day 14, 28 and 42 | 
| Compliance as assessed by capsule counts of the returned IP. |  | Day 14, 28 and 42 |