Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women

NCT07246161 | Recruiting Phase 2

• 2 other identifiers: L-03225AQ-1030
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Probiotics; Women's Health

Outcome Measures

Primary Outcomes (1)

• Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake

  28 days of oral intake

Secondary Outcomes (7)

• Presence or absence of the probiotic stains in the vaginal swabs at days 0 & 14 of oral intake, and 1 week after the end of intervention (Day 35)

  From enrollment to day 35

• Presence or absence of the probiotic strains in perineal skin swabs at days 0, 14, and 28 of oral intake.

  From enrollment to the 28th day.

• Presence or absence of the probiotic strains in stool samples at days 0, 14 and 28 of oral intake.

  From enrollment to 28th day

• Viability of the probiotic strains recovered from vaginal swabs at days 0, 14, and 28 of oral intake, and 1 week after the end of the intervention (Day 35)

  From enrollment to the 35th day.

• Viability of the probiotic strains recovered from perineal skin swabs at day 0, 14, and 28 of oral intake.

  From enrollment to 28th day

Other Outcomes (1)

• Number of adverse events (AEs) and serious adverse events (SAEs) reported throughout the study.

  From enrollment to the 35th day

Study Arms (3)

Group 1

EXPERIMENTAL

Other: Probiotic Formula 1

Group 2

EXPERIMENTAL

Other: Probiotic Formula 2

Group 3

EXPERIMENTAL

Other: Probiotic Formula 3

Interventions

Probiotic Formula 1 OTHER

Includes 2 different probiotic strains differing from other intervention groups.

Group 1

Probiotic Formula 2 OTHER

Includes 2 different probiotic strains differing from other intervention groups.

Group 2

Probiotic Formula 3 OTHER

Includes 2 different probiotic strains differing from other intervention groups.

Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Lallemand Health Solutions: lead

Study Sites (1)

Evalulab

Montreal, Canada

RECRUITING

Central Study Contacts

Jenna Bouassaly, MSc

CONTACT

5142835428; jbouassaly@lallemand.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 24, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

CA (1)