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Research has shown that babies who are exposed to HIV, but are uninfected (negative HIV status), have a bigger risk of developing severe infections. There are naturally occurring organisms in the gut that may determine how the body protects itself against infections. These organisms may be different in babies who were exposed to the HIV virus in utero, compared to those who were not exposed. This study wants to see if the organisms in the gut of babies can be modified by supplementing the diet of the pregnant mother or of the baby at 6 months of age with Inkomasi (pasteurized fermented milk). The study will compare the type and amount of organisms in those who received supplementation and those who did not receive supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inkomasi | Active Comparator | Diet supplementation with pasteurized fermented milk |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inkomazi | Dietary Supplement | Pasteurized fermented milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant gut microbiome | 16s rRNA and metagenomic sequencing | from enrollment to 4-10 weeks after enrollment |
| Maternal gut microbiome | Shotgun metagenomics and 16s rRNA | 4-10 weeks after initiation of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Adriana Weinberg, MD | AMC UCD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Witwatersrand | Johannesburg | South Africa |
NICHD database
After study publication
Demographic information will be deposited in the NICHD public database. Raw 16S rRNA gene sequences and shotgun metagenomic sequences, along with associated metadata, will be deposited in SRA following MIMARKS standard.
External investigators will be able to access the data using standard search methods.
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