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Recruiting NCT07246161

Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women

Conditions: Focus is on Healthy Subjects

Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 72
Sponsor: Lallemand Health Solutions

Location: Evalulab Montreal

Summary

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07246161). StuddyBuddy aggregates publicly available trial information.