HIV/AIDS Pregnancy and Childbirth Paediatrics Microbial Colonization and Infant Development
Conditions
Interventions
Active
Placebo
Sponsors
University of Cape Town
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Mother: 1) Willing and able to provide signed and dated informed consent form 2) 18 years of age or older 3) Documented HIV seropositive 4) Antiretroviral therapy initiated before the third trimester of pregnancy 5) Planning on exclusively breastfeeding the infant for the first 6 months of life Infant: Documented HIV seronegative at birth Born at term (completed at least 37 weeks of gestation) Birth weight >2.4kgs
Exclusion criteria
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 3) Any condition that in the opinion of the investigator would make participation in the trial unsafe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiome Alpha (Shannon) and Beta (Bray Curtis and UniFrac) diversity metrics on the entire microbial communities, assessed by bacterial shotgun metagenomics of infant stool, will be compared between treatment arms;Markers of intestinal inflammation and microbial translocation Markers of intestinal inflammation and microbial translocation (Lipocalin-2 (Lcn-2), sCD163, I-FABP and LBP measured by ELISA in infant plasma) will be compared cross-sectionally at each time point between groups using Mann-Whitney U tests;BCG vaccine respone Frequencies of total net cytokine producing cells in response to stimulation with BCG will be compared between arms.;BCG vaccine respone Frequencies of total net cytokine producing cells in response to stimulation with BCG will be compared between arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Longitudinal succession in gut microbiota composition, diversity and function Longitudinal multi-omic variation will be visualized using PCoA and tSNE plots, and cross-sectional differences in multi-omic profiles will be assessed using PERMANOVAs.;Stool metabolome For cross-sectional metabolite differential abundance analyses, we will use generalized linear regression (continuous dependent variable) and logistic regression (Boolean dependent variable) with an FDR correction.;T cell subsets frequencies T cell subsets frequencies will be compared cross-sectionally between groups | — |
Countries
South Africa
Contacts
Public ContactAnna Happel
Research Fellow
Outcome results
None listed