Condition: Hiv · Vaccine Reaction · Microbial Colonization · Sponsor: University of Cape Town
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
This description comes directly from the study's public registry record.
Heather Jaspan, MD PHD · 2068543336 · hbjaspan@gmail.com
Anna-Ursula Happel, PhD · + 27 21 406 6823 · anna.happel@uct.ac.za
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| Khayelitsha Site B Midwife Obstetric Unit | Cape Town, South Africa | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05923333