Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women
ConditionFocus is on Healthy Subjects
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorLallemand Health Solutions
About this trial
The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
Menopausal women,
Vaginal pH < 2 or > 5 measured at screening,
Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,
Use of vaginal probiotics in the last 3 months,
Trial design
Design model
Sequential
Treatments tested in this trial
Probiotic Formula 1
Other interventionProbiotic Formula 1
Probiotic Formula 2
Other interventionProbiotic Formula 2
Probiotic Formula 3
Other interventionProbiotic Formula 3
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake
Time frame
28 days of oral intakeSecondary outcomes
1
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 352
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.3
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 day4
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.Other outcomes
1
Number of adverse events (AEs) and serious adverse events (SAEs) reported throughout the study.
Time frame
From enrollment to the 35th daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov