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

The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on: * gut microbiome composition and diversity at 4 weeks of life * markers of intestinal inflammation and microbial translocation at 4 weeks of life * Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life The secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on: * longitudinal succession of the gut microbiota composition, diversity and function * relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life * stool metabolome * T cell subset ontogeny during the first 9 months of life. Exploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves: * infant growth * all-cause morbidity * neurodevelopment during the first 9 months of life * antibody responses to early childhood vaccines

NCT Number	NCT05923333
Lead Sponsor	University of Cape Town Collaborators: Seattle Children's Hospital, University of Stellenbosch, Institute for Systems Biology, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington
Conditions	Hiv, Vaccine Reaction, Microbial Colonization, Infant Development
Enrollment	200 participants
Start Date	2023-08-11
Primary Completion	2026-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2024-08-22