Human milk sugar plus probiotic for breastfed infants exposed to HIV
Trial of Human Milk Oligosaccharide-based synbiotics for HIV-exposed uninfected children
This gives a specific human milk sugar (2'FL) together with a B. infantis probiotic to breastfed infants born to mothers with HIV to try to reduce infections and help growth.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Columbia University Health Sciences NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project ID | NIH-11370504 on NIH RePORTER |
What this research studies
If your baby was born to a mother with HIV but did not acquire HIV, this project gives a supplement that combines a milk sugar (2'FL) and a probiotic (B. infantis) starting at four weeks of age. One hundred twenty breastfed HIV-exposed uninfected infants will be randomly assigned to the supplement or a placebo through 24 weeks, and all will be followed until 48 weeks; an additional 60 breastfed infants not exposed to HIV will be followed without intervention for comparison. The team will track infections, growth, and changes in the infant gut microbiome over time. The trial is carried out in rural South Africa where maternal HIV exposure and infant infectious risks are common.
Who could benefit from this research
Good fit: Breastfed infants who were exposed to HIV but remain uninfected, enrolled around 4 weeks of age and living near the rural South African study sites, would be the ideal candidates.
Not a fit: Infants who are HIV-infected, not breastfed, outside the enrollment age window, or living outside the study region would not be expected to benefit or be eligible.
Why it matters
Potential benefit: Could lower infection rates, improve growth, and reduce deaths among HIV-exposed but uninfected infants if successful.
How similar studies have performed: Earlier research links 2'FL and B. infantis to healthier infant gut bacteria and better growth, but this exact synbiotic combination in HIV-exposed uninfected infants is largely untested.
Where this research is happening
New York, United States
- Columbia University Health Sciences — New York, United States (Active)
Researchers
- Principal investigator: Shivakoti, Rupak — Columbia University Health Sciences
- Study coordinator: Shivakoti, Rupak
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.