Bifidobacterium breve to support bile flow in infants with cholestasis and biliary atresia
Official title: A phase 1/2 trial of Bifidobacterium breve supplementation in infants with cholestasis and suspected biliary atresia
Funded at Baylor College of Medicine · NIH-11356887 · Data updated 2026-11-12
A tiny study in babies with biliary atresia or related cholestasis tests a safe probiotic supplement (B. breve) to help bile flow after a surgical procedure.
Quick facts
| Grant type | R03 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Baylor College of Medicine NIH-funded |
| Lab location | 1 site (Houston, United States) |
| Project start | July 15, 2026 |
| Project end | June 30, 2028 |
| Funding year | 2026 |
| Award (this year) | $120,375 |
| NIH project number | 1R03DK147790-01 |
| Project ID | NIH-11356887 on NIH RePORTER |
Who could benefit from this research
✓Could help
Infants with biliary atresia or neonatal cholestasis undergoing Kasai portoenterostomy who are within the study timeframe.
✕Less likely to help
Infants who do not receive the probiotic or who have adverse reactions may not experience any improvement in bile flow.
What this research studies
This study will give newborns with cholestasis who undergo Kasai portoenterostomy a Bifidobacterium breve probiotic, along with prebiotics, to see if it improves jaundice clearance after surgery. Researchers will monitor safety, gut microbes, and bile flow markers over several months. The goal is to find a simple, non-surgical way to boost native liver function and reduce the chance of needing a transplant. Families will be informed about risks and follow-up visits as part of routine care.
Why it matters
Potential benefit: If successful, the probiotic approach could improve bile flow after surgery and possibly spare some infants from early liver transplant.
How similar studies have gone: Prior work links gut microbiome composition to bile flow outcomes; this is a novel application using B. breve around Kasai surgery.
Where this research is happening
-
Baylor College of Medicine
Houston, United States Active
Researchers
- Principal investigator: Tessier, Mary Elizabeth Mcconnell — Baylor College of Medicine
- Study coordinator: Tessier, Mary Elizabeth Mcconnell
Related research
Other NIH-funded projects on the same topics.
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Genetic factors in virus-related biliary atresia in children
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This research explores how certain immune cells called neutrophils cause liver scarring in babies born with biliary atresia.
-
Investigating the role of the microbiome in biliary atresia
This study is looking at how the bacteria in the gut might affect the health of babies with biliary atresia, a liver condition, by collecting stool samples to see if there are differences between those who do and don’t have successful bile flow after surgery, with the hope of finding ways to improve their care.
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.