Could a simple supplement protect HIV-Exposed babies from infections?

NCT ID NCT05282485

Completed Disease control Sponsor: Columbia University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study tests whether a synbiotic supplement (a mix of a prebiotic called 2'-FL HMO and a probiotic called B. infantis) can reduce infections and improve growth in infants who were exposed to HIV but are not infected themselves. About 140 infants will receive either the supplement or a placebo from 4 to 24 weeks of age. Researchers will track infections, growth, and development up to 72 weeks old.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Synbiotic (2'-FL human milk oligosaccharide + Bifidobacterium infantis probiotic)
What this could lead to: If it works, this could offer a simple dietary supplement to help HIV-exposed infants fight infections and grow better, reducing health gaps compared to unexposed babies.
What could go wrong: This is a small, early-stage trial with 140 infants, so results may not apply broadly. The supplement may cause digestive discomfort or show no benefit over placebo.

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Conditions

The condition(s) this trial relates to.

Breast Feeding HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST FEEDING HIV INFANT MORBIDITY

Contacts and locations

Locations

Worcester Campus of Stellenbosch University (SU)

Stellenbosch, Western Cape, 7599, South Africa

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