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

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