This study is designed to evaluate the impact of oral consumption of the probiotic yeast CNCM I-3856 on healthy vaginal microbiota
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Experimental arm
Experimental arm
Placebo comparator arm
Biofortis Mérieux Nutriscience
Saint-Herblain, France
S cerevisiae transfer from the gut to the vagina
Proportion of subjects presenting the yeast strain S cerevisiae CNCM I-3856 (presence) in their vaginal microbiota after a 4-week daily supplementation
Time frame: Day 28
S cerevisiae transfer from the gut to the vagina
Proportion of subjects presenting the yeast strain S cerevisiae CNCM I-3856 (presence) in their vaginal microbiota after 1, 2 or 3-week daily supplementation and after a 2-week observation period without supplementation
Time frame: Day 7, Day 14, Day 21, Day 42
Quantification of S cerevisiae in the vagina
Value at Day 7, 14, 21, 28, 42 and change Day 42 - Day 28 of S cerevisiae CNCM I-3856 (CFU/ sample) in the vaginal microbiota
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Impact on 4 predominant Lactobacilli species
Changes of 4 dominant Lactobacilli species (number of copies per sample) by comparison of the 3 groups at each time change
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Association between intestinal and vaginal microbiota for the presence of S cerevisiae CNCM I-3856
Evaluation of the presence of S cerevisiae CNCM I-3856 in the vaginal microbiota considering its presence in the intestinal microbiota in each active group.
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Correlation between the quantity of S cerevisiae CNCM I-3856 (CFU/sample) in the intestinal microbiota and vaginal microbiota
Correlation between the quantity of S cerevisiae CNCM I-3856 (CFU/sample) in the intestinal microbiota and vaginal microbiota in each active group.
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Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Presence of Candida albicans in the vaginal microbiota
In each group, at each time point according to Day 0 and at Day 42 according to Day 28
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Evolution of the presence of Candida albicans in the vaginal microbiota
Changes of Candida albicans (CFU/samples) in the vaginal microbiota
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42