A Phase 2 interventional study of Probiotic Formula 1 and Probiotic Formula 2 in Focus is on Healthy Subjects, sponsored by Lallemand Health Solutions. Recruiting at 1 site in Canada. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Lallemand Health Solutions · Phase 2, Interventional, and Other
The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.
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 transiently 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.
Lallemand Health Solutions is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Vaginal pH \< 2 or > 5 measured at screening,
•. Menstruation during the sample collection times,
Other: Probiotic Formula 1
Other: Probiotic Formula 2
Other: Probiotic Formula 3
Probiotic Formula 1
Probiotic Formula 2
Probiotic Formula 3
Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake
Time frame: 28 days of oral intake
Presence or absence of the probiotic stains in the vaginal swabs at days 0 & 14 of oral intake, and 1 week after the end of intervention (Day 35)
Time frame: From enrollment to day 35
Presence or absence of the probiotic strains in perineal skin swabs at days 0, 14, and 28 of oral intake.
Time frame: From enrollment to the 28th day.
Presence or absence of the probiotic strains in stool samples at days 0, 14 and 28 of oral intake.
Time frame: From enrollment to 28th day
Viability of the probiotic strains recovered from vaginal swabs at days 0, 14, and 28 of oral intake, and 1 week after the end of the intervention (Day 35)
Time frame: From enrollment to the 35th day.
Viability of the probiotic strains recovered from perineal skin swabs at day 0, 14, and 28 of oral intake.
Time frame: From enrollment to 28th day
Changes in vaginal pH from baseline to 1 week after the end of the intervention (Day 35)
Time frame: From baseline to day 35.
Changes in the abundance of endogenous and pathogenic bacterial and fungal species in the vagina at days 0, 14, 28 and 35.
Time frame: From enrollment to the 35th day
Number of adverse events (AEs) and serious adverse events (SAEs) reported throughout the study.
Time frame: From enrollment to the 35th day
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Lallemand Health Solutions