The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions

What this Trial Is About

Researchers are evaluating whether giving a probiotic called Bifidobacterium longum subspecies infantis Bifin02 (B. infantis) to healthy newborns can affect their immune function, reduce bacterial infections and antibiotic use, and influence overall health, development, growth, and the risk of inflammatory, allergic, and autoimmune diseases. This randomized, placebo-controlled, double-blinded intervention trial aims to explore how B. infantis impacts the infant gut microbiome and various health outcomes. Newborn participants will be randomly assigned to receive either the B. infantis probiotic or a placebo daily by oral administration for three weeks starting at 7 days of age. The probiotic is given as a dietary supplement powder to be mixed with human milk or clean water. The study includes a placebo group receiving an identical-looking substance without the probiotic. Parents will administer the supplement and provide consent and information. Participants and their parents will engage in several activities including completing baseline and follow-up questionnaires through a study app, collecting five stool samples from the child and one from the mother, and gathering a four-week passive dust sample at home. The child will also provide dried blood spots and a blood sample. Researchers will track outcomes such as antibiotic prescriptions over 18 years, gut microbiota composition, inflammatory markers, growth, allergies, and body composition. The study began in June 2024 and follows participants up to 18 years.

The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial