Methods Study design
and sample collection A pilot, not randomized, controlled and perspective study was conducted. The study protocol was approved by the ethical committee of the University of Bari, Italy. Written informed consent was obtained from all the participants in the study. A total of 27 healthy pregnant women (21 to 42 years of age; mean, 32) who had no symptoms of vaginal or urinary tract infection were included in the present study (Table 3). None of the PND-1186 manufacturer subjects had received oral or local Selleck MK-8931 antimicrobial therapy within the previous 2 weeks. The recruited subjects were divided into 2 groups: (i) probiotic group [P (n=15)]; (ii) control group [C (n=12)] on the basis of their availability to consume the probiotic product. Women of the P group consumed 1 sachet once/day of VSL#3 (VSL Pharmaceuticals, Inc.,Towson, MD, USA) for 4 weeks from the 33rd (W33) to the 37th (W37) week of gestation. Women of the C group did not receive any dietary supplementation. VSL#3 sachet contains 900 billion viable lyophilized bacteria consisting of 4 strains of Lactobacillus (L. paracasei, L. plantarum, L. acidophilus,
L. delbrueckii MLN2238 datasheet subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, B. breve, B. infantis) and 1 strain of Streptococcus thermophilus. Mid-vaginal swabs were collected from women of both P and C groups at the time points W33 and W37. Samples were placed in 1 ml of sterile saline and stored immediately at −80°C until use. Table 3 Characterization of the subjects included in the study groups Woman N Age Type of delivery1 Gestational age at birth Probiotic very (n = 15) 1 31 SD 39 week + 6 days 2 32 CD 40 week + 3 days 3 39 SD 40 week + 1 day 4 31 SD 40 week + 2 days 5 33 SD 40 week + 3 days 6 30 SD 39 week 7 33 SD 41 week + 3 days 8 34 CD 39 week 9 36 CD 38
week + 4 days 10 38 SD 38 week + 5 days 11 42 SD 39 week + 4 days 12 30 SD 39 week 13 29 SD 40 week + 2 days 14 33 CD 39 week + 2 days 15 25 SD 40 week + 1 day Control (n = 12) 16 28 SD 40 week + 6 days 17 33 SD 39 week + 3 days 18 33 CD 37 week + 4 days 19 32 CD 41 week + 3 days 20 34 SD 40 week 21 21 SD 39 week + 5 days 22 30 SD 38 week + 6 days 23 30 SD 40 week + 2 days 24 34 CD 39 week + 6 days 25 38 CD 41 week + 1 days 26 38 CD 38 week + 5 days 27 30 SD 40 week + 2 days 1 SD: spontaneous delivery; CD: caesarean delivery. The individual characteristics (age, type of delivery and gestational age at birth) of women enrolled in the present study are reported in Table 3. Gestational age was determined by utilizing the last menstrual period and earliest ultrasound. DNA extraction from vaginal samples Frozen vaginal swabs were thawed, mixed by vortex shaker for 1 min and then removed from the liquid.