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OpenTrials
Enrolling by Invitation

NCT Number: NCT07052409

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.

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Key information

Conditions

Gut Microbiome

Age range

6 month–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Witwatersrand

Johannesburg, South Africa

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women with HIV HIV-exposed uninfected infants

Exclusion criteria

-

Treatment and study plan

Inkomazi

Dietary Supplement

Pasteurized fermented milk

Primary outcomes

  1. Infant gut microbiome

    Time frame: from enrollment to 4-10 weeks after enrollment

    16s rRNA and metagenomic sequencing

  2. Maternal gut microbiome

    Time frame: 4-10 weeks after initiation of the intervention

    Shotgun metagenomics and 16s rRNA

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 4, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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