Who is conducting this study?
This clinical study is led by Dr. Jennifer Smilowitz, Ph.D., at the UC Davis Foods for Health Institute and Dr. Mark Underwood, M.D., at the UC Davis Medical Center. This study has been reviewed and approved by the UC Davis Institutional Review Board.
What is the purpose of this study?
We are trying to understand if a probiotic culture called Bifidobacterium longum subspecies infantis (B. infantis) fed with breastmilk for 21 days to babies who are exclusively breastfed will increase levels of this beneficial culture in their digestive tracts. Recent medical discoveries have found that intestinal levels of B. infantis help with the development of the baby’s gut and provide protection against intestinal pathogens. Data coming in from around the world over the past 5 years point to B. infantis as universally associated with all newborn babies, and that this culture is naturally introduced to babies who are born vaginally and breastfed. However, we have found that babies born by C-section, and even a growing number of vaginal deliveries here in the United States are resulting in babies with very low levels of intestinal B. infantis.
Healthy term infants delivered vaginally or by C-section and their mothers will be randomized into one of two groups: 1) the supplement group in which infants consume B. infantis and their mothers receive lactation support or, 2) the matched-control group in which mothers receive lactation support. All participants enrolled in this study will receive standard care and four in-home complimentary lactation consultation visits.
Who can participate?
Healthy, non-smoking pregnant women in their third trimester of pregnancy; OR women who have delivered healthy term infants within the past 2 days and plan to breastfeed their infants; and their healthy term infants will be enrolled.
This project is funded by Evolve Biosystems Inc. Click to view our medical brochure for the IMPRINT product.
For more information please contact the Study Coordinator, Melissa Breck (888) 217-5355 or email at: firstname.lastname@example.org
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