Bifidobacterium infantis supplementation in early life to improve immunity in infants exposed to HIV: a randomized, placebo-controlled, double-blind trial

Phase 2

Not yet recruiting

Conditions: Pregnancy and Childbirth
Paediatrics

Registration Number: PACTR202301748714019

Lead Sponsor: niversity of Cape Town

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 200

Inclusion Criteria

1) HIV uninfected at birth
2) Delivered at term
3) No pregnancy or delivery complications including birth asphyxia, seizures, sepsis, birth weight
4) >2.4kgs, and no known contraindications to probiotic supplementation

Exclusion Criteria

Mother: 1) Complications during pregnancy and delivery such as gestational diabetes, obesity (BMI> 35 prior to pregnancy), chorioamnionitis and eclampsia
2) Active TB or other infectious diseases
3) Administration of probiotics, prebiotics or immunoregulatory products
Infant: 1) Hypoxic injury/ seizures/ sepsis/ Intrauterine growth retardation
2) Administration of probiotics, prebiotics or immunoregulatory products