Recruiting

Phase 2

ProbioticsVaginal Detection of Orally Delivered Probiotic Strains in Healthy Women

Sponsor:

Lallemand Health Solutions

Code:

NCT07246161

Conditions

Focus is on Healthy Subjects

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Probiotic Formula 1

Probiotic Formula 2

Probiotic Formula 3

Study Details

Brief summary:

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

Conditions

Focus is on Healthy Subjects

Study ID

NCT07246161

Start date

Oct 20, 2025

Status verified date

Jun, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion 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.

Exclusion Criteria:

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group 1

experimental: Group 2

experimental: Group 3

Interventions

Probiotic Formula 1

Probiotic Formula 2

Probiotic Formula 3

Primary outcome measure

Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake [ Time Frame: 28 days of oral intake ]

Central Contacts and Locations

Central contacts

Jenna Bouassaly, MSc

514-223-2057 jbouassaly@lallemand.com

Locations

Evalulab

Recruiting

Montreal, Canada

Contacts

Evalulab

514-434-0001

More Information

Sponsor

Lallemand Health Solutions

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

Probiotics
Women's Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lallemand Health Solutions on 2026-06-18.