2.1. Study Design, Population, and Products
A multicentre, randomized, double-blind, controlled clinical study was carried out in Italy, in compliance with the Helsinki Declaration (1964) and its amendment. This study’s protocol was approved by the “Independent Ethical Committee for Non-Pharmacological Clinical Studies” (Genova, Italy). Written informed consent was obtained from all subjects before enrolment. This study was registered at the ISRCTN registry (registration number: ISRCTN99047904). Subject enrolment was carried out between July 2020 and July 2021. Two hundred healthy Italian (Caucasian) pregnant women, aged between 18 and 50 years old, were enrolled according to the inclusion and exclusion criteria reported in Subjects were randomly assigned to 2 groups according to a randomization list previously generated using the statistical algorithm “Wey’s urn”. The two groups (95 subjects each) were provided with two different products as follows: one group used the probiotic plus multivitamin food supplement (active treatment), while the other group used the multivitamin food supplement only (control treatment). The active product contained two probiotic strains, named 