Developing Interventions for Protecting HIV-Exposed Uninfected Infants Against Severe Infections

University of Colorado Denver (CU Denver)

Status: Invitation-only

Conditions: Gut Microbiome

Treatments: Dietary Supplement: Inkomazi

Study type: Interventional

Funder types: Other

Identifiers

NCT07052409

24-1383 COMIRB

Details and patient eligibility

About

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.

Full description

1. 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.
2. 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 6 months to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women with HIV HIV-exposed uninfected infants

Exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Inkomasi

Active Comparator group

Description:

Diet supplementation with pasteurized fermented milk

Treatment:

Dietary Supplement: Inkomazi

Control

No Intervention group

Description:

No intervention