Evaluation of Faecal Microbiota Following Probiotics in Infants of Mothers with Gestational Diabetes Mellitus Trial: Protocol for Double-Blind Placebo-Controlled Randomized Trial.

(1) Background: The incidence of gestational diabetes mellitus (GDM) is rising globally. The current evidence indicates that GDM, especially in conjunction with maternal overweight, can alter the composition of infants' gut microbiota, potentially increasing the risk of inflammatory diseases, metabolic disorders, and neurodevelopmental issues later in life. Probiotic supplantation early in life might establish eubiosis and mitigate future complications. To best of our knowledge, no study has evaluated the effects of probiotics on gut dysbiosis in the infants of mothers with GDM. (2) Methods: This study will be a single-centre, double-blind, randomized, placebo-controlled trial enrolling sixty neonates born after 35 weeks of gestation to mothers with GDM. The participants will be randomly assigned to receive either a triple-strain probiotic or a placebo for four months. The primary objective is to assess the effectiveness of probiotic supplementation in correcting gut dysbiosis in the infants of mothers with GDM at four months of age. Faecal microbiome composition shall be estimated using 16SrRNA and shotgun sequencing. The secondary outcomes will include the quantification of faecal short-chain fatty acids at birth and at four months, as well as growth and developmental assessments at four, twelve, and twenty-four months. (3) Trial registration: This trial protocol is registered (ACTRN12624000930583p) in the Australian Clinical Trials registry (ANZCTR).