Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women (VSS2)

Lallemand

Status and phase: Enrolling; Phase 2

Conditions: Focus is on Healthy Subjects

Treatments: Other: Probiotic Formula 3; Other: Probiotic Formula 2; Other: Probiotic Formula 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07246161

L-032

25AQ-1030 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Group 1

Experimental group

Treatment:

Other: Probiotic Formula 1

Group 2

Experimental group

Treatment:

Other: Probiotic Formula 2

Group 3

Experimental group

Treatment:

Other: Probiotic Formula 3