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

Phase 2

• Conditions: Pregnancy and Childbirth; Paediatrics

• Registration Number: PACTR202301748714019
• Lead Sponsor: niversity of Cape Town

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-20
• Last Update Posted: 29 May 2023

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare gut microbial structure and function longitudinally in iHEU infants randomized to receive B. infantis versus placebo in early life and to evaluate associations with stool metabolome

Secondary Outcome Measures

Name	Time	Method
To compare gut mucosal integrity and regulatory: inflammatory cell ratios in iHEU who receive early life B. infantis versus placebo;To compare T cell responsiveness to BCG vaccination and linear growth in iHEU who receive early life B. infantis versus placebo