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

Study acronym: BifIID
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 22, 2024 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2023 to Aug 11, 2023
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
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
(from sponsor)		 Hiv, Vaccine Reaction, Microbial Colonization, Infant Development
Related terms Acquired Immunodeficiency Syndrome, Communicable Diseases
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov