B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV (BifIID)
Hiv, Vaccine Reaction, Microbial Colonization
About this trial
This is an interventional treatment trial for Hiv
Eligibility Criteria
Inclusion Criteria Mother: Willing and able to provide signed and dated informed consent form 18 years of age or older Documented HIV seropositive Antiretroviral therapy initiated before the third trimester of pregnancy Planning on exclusively breastfeeding the infant for the first 6 months of life Inclusion Criteria Infant: Documented HIV seronegative at birth Born at term (completed at least 37 weeks of gestation) Birth weight >2.4kgs Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
B. infantis Rosell®-33
Placebo
Participants will receive 8 x 109 CFU B. infantis Rosell®-33 per dose (single microbial active ingredient) and carrier material (maltodextrin) for 28 days from day 1-3 of life.
Participants will receive placebo (containing all materials besides B. infantis Rosell®-33) for 28 days from day 1-3 of life.