NIH-funded research R01 grant

Bifidobacterium infantis in infancy to boost immunity for babies exposed to HIV

Official title: Bifidobacterium infantis supplementation in early life to improve immunity in infants exposed to HIV: a randomized, placebo-controlled, double-blind trial

Funded at Seattle Children's Hospital · NIH-11474044 · Data updated 2026-11-12

A small trial will test whether giving a probiotic B. infantis to breastfed infants exposed to HIV but uninfected can help boost their developing immune system.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionSeattle Children's Hospital
NIH-funded
Lab location1 site (Seattle, United States)
Project startJune 1, 2022
Project endApril 30, 2027
Funding year2026
Award (this year)$84,542
NIH project number3R01HD109089-05S1
Project IDNIH-11474044 on NIH RePORTER

Who could benefit from this research

Could help

Breastfed, HIV-exposed but uninfected infants in South Africa, enrolled in early life.

Less likely to help

Infants not exposed to HIV or not meeting breastfeeding criteria may not benefit from this specific intervention.

What this research studies

Infants exposed to HIV but not infected can have weaker immunity and altered gut bacteria. In this study, 200 such infants in South Africa will be randomly assigned to receive either Bifidobacterium longum subspecies infantis or a placebo during early life, with researchers and participants blinded to group assignment. The team will monitor gut microbes and metabolism over time using stool samples and advanced sequencing and metabolomics techniques. Outcomes will focus on immune-related changes and potential links to health later in childhood. This research could point to a simple, safe way to support immunity in a vulnerable population.

Why it matters

Potential benefit: If successful, it could lead to a practical probiotic strategy to improve immunity and health in infants exposed to HIV.

How similar studies have gone: Prior evidence suggests B. infantis can influence gut microbiota and immunity, but this exact birth-to-immunity link in iHEU is being tested.

Where this research is happening

  • Seattle Children's Hospital
    Seattle, United States
    Active

Researchers

  • Principal investigator: Jaspan, Heather Beryl — Seattle Children's Hospital
  • Study coordinator: Jaspan, Heather Beryl

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.