B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Hiv, Vaccine Reaction, Microbial Colonization, Infant Development
In brief
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
Key facts
- Study ID
- NCT05923333
- Run by
- University of Cape Town
- People needed
- 200
- Starts
- 2023-08-11
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2024-08-22
Who can join
Age: any, up to 50. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Severe illnesses, e.g. Sepsis
- current TB or known household TB contact
- Chronic disorder or medications (other than antiretrovirals and cotrimoxazole prophylaxis) that in the opinion of the investigator would alter immunity
- Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies or congenital infections
- Known contraindications to components of the interventional products
- Taking additional probiotics or prebiotics
- Any condition that in the opinion of the investigator would make participation in the trial unsafe
Where it is running
- Khayelitsha Site B Midwife Obstetric Unit — Cape Town, South Africa (enrolling)
Full record on ClinicalTrials.gov
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