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

Not Applicable

• Conditions: Gut Microbiome

• Registration Number: NCT07052409
• Lead Sponsor: University of Colorado, Denver

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

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.

Study Timeline

• Study Start: 2025-04-10
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-09
• Primary Completion: 2028-06
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Pregnant women with HIV HIV-exposed uninfected infants

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Infant gut microbiome	from enrollment to 4-10 weeks after enrollment	16s rRNA and metagenomic sequencing
Maternal gut microbiome	4-10 weeks after initiation of the intervention	Shotgun metagenomics and 16s rRNA

Trial Locations

Locations (1)

Witwatersrand; 🇿🇦 Johannesburg, South Africa