Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women

Recruiting now · Phase 2

Conditions studied: Focus is on Healthy Subjects

In brief

The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.

Key facts

Study ID

NCT07246161

Run by

Lallemand Health Solutions

People needed

72

Starts

2025-10-20

Expected to finish

2026-10-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify 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 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.

You may not qualify if…

• Menopausal women,
• Vaginal pH < 2 or > 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.

Where it is running

• Evalulab — Montreal, Canada (enrolling)

Full record on ClinicalTrials.gov

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