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Official title Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women
ClinicalTrials.gov ID: NCT07246161
What this study is testing
- What it's testing
- The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- Clinically healthy female between the ages of 18 and 50 years, inclusive,
- have a regular or predictable menstrual cycle
- Typically have regular bowel movements,
- Willing and able to consume a probiotic supplement for 4 weeks,
- Willing to discontinue consumption of probiotic supplement and probiotic-fortified products 2 weeks before the start of the study and throughout the...
You likely can't join if
- Menopausal women,
- Vaginal pH \ 5 measured at screening, . Menstruation during the sample collection times,
- Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,
- Use of vaginal probiotics in the last 3 months,
- Use of local vaginal antibiotics or antifungals in the last 3 months.
- Use of oral antibiotics or antifungals in the last month,
See the full eligibility criteria
- Clinically healthy female between the ages of 18 and 50 years, inclusive,
- have a regular or predictable menstrual cycle
- Typically have regular bowel movements,
- Willing and able to consume a probiotic supplement for 4 weeks,
- Willing to discontinue consumption of probiotic supplement and probiotic-fortified products 2 weeks before the start of the study and throughout the study,
- Willing to discontinue fiber supplements 2 weeks before the start of the study, and throughout the study,
- Willing to provide 1 stool sample 4 times throughout the study,
- Willing to provide 2 vaginal swabs 4 times throughout the study,
- Willing to undergo vaginal pH swab measurements (with a swab) 5 times throughout the study,
- Willing to provide 2 perineal skin swabs (skin between the vagina and the anus) 3 times throughout the study,
- Willing to complete a pregnancy test at the screening visit.
- Menopausal women,
- Vaginal pH \ 5 measured at screening, . Menstruation during the sample collection times,
- Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,
- Use of vaginal probiotics in the last 3 months,
- Use of local vaginal antibiotics or antifungals in the last 3 months.
- Use of oral antibiotics or antifungals in the last month,
- Ongoing symptoms of vaginal and/or urinary tract infections,
- Current treatment for vaginal sepsis or urosepsis,
- Currently being treated for a severe chronic disease (e.g. cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.),
- Clinical diagnosis of a gynecological disease or condition (e.g, fibroma, endometriosis, polycystic ovarian syndrome, etc.),
- Clinical diagnosis of secondary dysmenorrhea,
- Intolerance, allergy or sensitivity to milk, soy, or yeast.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.