Orally administered multispecies probiotic formulations to prevent uro-genital infections: a randomized placebo-controlled pilot study.
OBJECTIVE
The aim of this study was to evaluate in the vagina of 60 pre-menopausal women the detection of orally administered multispecies probiotic formulations showing anti-microbial properties in test in vitro.


METHODS
A randomized, double-blind, three-arm parallel pilot study was carried out on 60 pre-menopausal women. Subjects were randomly divided in three groups (F_1, F_2, F_3). Each group received a daily oral administration of probiotic mixtures (for 14 days and at the day 21, 7 days after the wash-out) containing: Lactobacillus acidophilus and Lactobacillus reuteri (F_1), or Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis (F_2), or placebo (F_3), respectively. Vaginal swabs were collected at four experimental times, at t0 and at t7, t14 and t21 days, and analyzed by qPCR. At the same time, the anti-microbial activity of the probiotic formulations was verified by assays in vitro against microorganisms as Escherichia coli and Candida albicans.


RESULTS
L. acidophilus and L. reuteri as well as L. plantarum, L. rhamnosus and B. lactis were significantly increased on 7 days in the groups administered with F_1 and F_2, respectively, compared to group F_3. A similar significant trend was observed on 21 days, 7 days after the wash-out. F_1 and F_2 showed coherent anti-microbial properties.


CONCLUSIONS
Both probiotic formulations F_1 and F_2, chosen because of their anti-microbial activity against pathogens responsible for vaginal dysbiosis and infections, led to vaginal detection and enhancement of the amount of species of formulates when orally administered. This work provides the basis for further clinical investigations of the F_1 and F_2 capacity to prevent or treat uro-genital infections.
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126, Milan, Italy.
Valerio
V
Mezzasalma
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126, Milan, Italy.
Enrico
E
Manfrini
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126, Milan, Italy.
Emanuele
E
Ferri
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126, Milan, Italy.
Marco
M
Boccarusso
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126, Milan, Italy. patrizia.digennaro@unimib.it.
Patrizia
P
Di Gennaro
Farcoderm Srl, Via Angelini 21, 27028, San Martino Siccomario, Pavia, Italy.
Irene
I
Schiano
Farcoderm Srl, Via Angelini 21, 27028, San Martino Siccomario, Pavia, Italy.
Angela
A
Michelotti
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126, Milan, Italy.
Massimo
M
Labra
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002176:Candida albicans; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007779:Lactobacillus acidophilus; D052201:Lacticaseibacillus rhamnosus; D008875:Middle Aged; D010865:Pilot Projects; D019936:Probiotics / Q000008:administration & dosage*; D014621:Vagina / Q000382:microbiology*; D055815:Young Adult
Bifidobacterium; Lactobacillus; Probiotics; Uro-vaginal infections; Vaginal colonization; qPCR