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

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.

NCT Number	NCT07052409
Lead Sponsor	University of Colorado, Denver
Conditions	Gut Microbiome
Enrollment	72 participants
Start Date	2025-04-10
Primary Completion	2028-06 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-15