Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial

What this Trial Is About

Researchers are studying the effects of early-life supplementation with Bifidobacterium infantis Rosell44-33 in infants who were exposed to HIV but are not infected. This randomized, placebo-controlled trial aims to assess how this supplement influences the gut microbiome, intestinal inflammation, microbial translocation, and immune responses to the BCG vaccine. The study also explores potential benefits on infant growth, illness rates, neurodevelopment, and antibody responses to early vaccines during the infants' first nine months of life. The study enrolls 200 breastfed infants born to mothers with HIV in South Africa, randomly assigning them to receive either B. infantis Rosell44-33 or a placebo daily for the first 28 days starting within the first three days after birth. The supplement contains 8 x 10^9 colony-forming units of B. infantis plus maltodextrin, while the placebo includes maltodextrin alone. Infants are followed closely for 36 weeks with ongoing collection of data and biological samples. Participants will undergo assessments of gut microbiome composition and diversity, markers of intestinal health, and immune responses to BCG vaccination at multiple time points, including 4, 7, and 36 weeks of age. Additional evaluations include stool metabolome analysis, T cell subset monitoring, growth tracking, morbidity recording, and neurodevelopmental testing. The study includes detailed monitoring to understand the supplement's impact on immunity and overall infant health over the first nine months of life.

B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV