Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT07246161
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07246161
Study Brief:
Protocol Section:
NCT07246161