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RecruitingPhase 2NCT07246161

Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women

Detection of Orally Delivered Probiotic Strains in the Vaginal Microbiome of Healthy Female Adults

Sponsor

Lallemand Health Solutions

Enrollment

72 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Focus is on Healthy Subjects

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria11

  • 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.

Exclusion Criteria13

  • 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.

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Interventions

OTHERProbiotic Formula 1

Includes 2 different probiotic strains differing from other intervention groups.

OTHERProbiotic Formula 2

Includes 2 different probiotic strains differing from other intervention groups.

OTHERProbiotic Formula 3

Includes 2 different probiotic strains differing from other intervention groups.

Locations(1)

Evalulab

Montreal, Canada

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NCT07246161