PACTR202301748714019
Not yet recruiting
Phase 2
Bifidobacterium infantis supplementation in early life to improve immunity in infants exposed to HIV: a randomized, placebo-controlled, double-blind trial
niversity of Cape Town0 sites200 target enrollmentJanuary 20, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pregnancy and Childbirth
- Sponsor
- niversity of Cape Town
- Enrollment
- 200
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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