Developing Interventions for Protecting HIV-Exposed Uninfected Infants Against Severe Infections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Infant gut microbiome
Study Overview
Brief Summary
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.
Detailed Description
- The study will enroll 24 pregnant women with HIV at 36 weeks gestational age and randomize them 1:1 to receive 500 ml daily of pasteurized fermented milk (Inkomasi) or not. Changes in maternal gut microbiota from enrollment to 2-4 weeks postpartum will be compared between groups. The study will also compare the gut microbiome at infants born to mothers who received Inkomasi with those born to mothers who did not receive Inkomasi.
- The study will enroll 24 HIV-exposed uninfected infants (HEU) at 24 weeks of age and randomize them 1:1 to receive ≥15 ml daily of pasteurized fermented milk (Inkomasi) or not. Changes in infant gut microbiota from enrollment to 4 weeks after enrollment will be compared between groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women with HIV HIV-exposed uninfected infants
Exclusion Criteria
- Not provided
Arms & Interventions
Inkomasi
Diet supplementation with pasteurized fermented milk
Intervention: Inkomazi (Dietary Supplement)
Control
No intervention
Outcomes
Primary Outcomes
Infant gut microbiome
Time Frame: from enrollment to 4-10 weeks after enrollment
16s rRNA and metagenomic sequencing
Maternal gut microbiome
Time Frame: 4-10 weeks after initiation of the intervention
Shotgun metagenomics and 16s rRNA
Infant gut microbiome
Time Frame: from enrollment to 4-10 weeks after enrollment
16s rRNA and metagenomic sequencing
Maternal gut microbiome
Time Frame: 4-10 weeks after initiation of the intervention
Shotgun metagenomics and 16s rRNA
Secondary Outcomes
No secondary outcomes reported
Investigators
Adriana Weinberg
Professor of Pediatrics, Medicine and Pathology
University of Colorado, Denver