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โ† Trials
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Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women

RecruitingPhase 2Ages 18 Years - 50 YearsFemaleLallemand Health Solutions
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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, โ€ข. 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.
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What it tests

  • Probiotic Formula 1
  • Probiotic Formula 2
  • Probiotic Formula 3
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Where

1 site
Evalulab
Montreal, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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