Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women

NCT ID: NCT07246161

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2026-06-30

Brief Summary

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

Detailed Description

Probiotics have emerged as novel supplements to support women's health, demonstrating benefits in maintain vaginal health and promoting recovery from dysbiosis. This includes various oral and vaginal probiotics shown to alleviate symptoms and enhance the reversal of vaginal dysbiosis.

Oral delivered probiotic strains suggest their ability to migrate and colonize the vagina to support vaginal health but is not well understood. Therefore, this study will aim to provide additional information on their transit to the vagina.

Conditions

Focus is on Healthy Subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

Group Type: EXPERIMENTAL

Probiotic Formula 1

Intervention Type: OTHER

Includes 2 different probiotic strains differing from other intervention groups.

Group 2

Group Type: EXPERIMENTAL

Probiotic Formula 2

Intervention Type: OTHER

Includes 2 different probiotic strains differing from other intervention groups.

Group 3

Group Type: EXPERIMENTAL

Probiotic Formula 3

Intervention Type: OTHER

Includes 2 different probiotic strains differing from other intervention groups.

Interventions

Probiotic Formula 1

Includes 2 different probiotic strains differing from other intervention groups.

Intervention Type: OTHER

Probiotic Formula 2

Includes 2 different probiotic strains differing from other intervention groups.

Intervention Type: OTHER

Probiotic Formula 3

Includes 2 different probiotic strains differing from other intervention groups.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lallemand Health Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Evalulab

Montreal, , Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jenna Bouassaly, MSc

Role: CONTACT

jbouassaly@lallemand.com

5142835428

Facility Contacts

Evalulab

Role: primary

514-434-0001

Other Identifiers

25AQ-1030

Identifier Type: OTHER

Identifier Source: secondary_id

L-032

Identifier Type: -

Identifier Source: org_study_id