What is this study about?

We are trying to understand how feeding a baby-specific probiotic supplement for 28 days to 2 to 4 month old breastfed infants, increases levels of protective bacteria in their stool. Probiotics are beneficial bacteria that are consumed by mouth as supplements. The probiotic used in the REMEDI Study is called Bifidobacterium infantis (B. infantis) which has historically been found in high amounts in the gut of breastfed infants. Breast milk contains complex carbohydrates that are not digested by babies but specifically feed B. infantis found in the infant’s gut. We recently discovered that in the past 100 years, there has been a generational loss of Bifidobacterium in the gut of breastfed infants and this reduction of protective bacteria in the gut which is linked to higher levels of bad bacteria in the gut.1 We also know that infants from developed or resource-rich countries such as the United States have less protective Bifidobacterium in their gut than babies born in developing or resource-poor countries.

These observations are likely attributed to the unintended consequences of medical interventions used in developed nations such as the overuse of antibiotics, high cesarean section rates and use of infant formula. Low levels of the protective or good bacteria in the gut and high levels of pathogenic or bad bacteria in the gut during infancy has been linked to higher risk of short and long-term immune and metabolic issues such as asthma, allergy, type 1 diabetes and obesity.2-5

In our landmark clinical trial, the IMPRINT Study, B. infantis supplementation in breastfed newborns was well-tolerated6 and corrected the stool pH, and restored the gut microbiome by increasing protective Bifidobacterium and reducing bad bacteria by 80% in the gut.7

In the REMEDI Study, we are investigating the effect of feeding a high, medium, or low dose of B. infantis against a placebo-control supplement on changes in fecal bacteria in older exclusively breastfed infants (2 to 4 months of age). In the REMEDI study, we are using the same B. infantis strain (EVC001) that was used in the IMPRINT Study. The medium dose used in the REMEDI Study, is commercially available and called Evivo.


  1. Henrick, B. M.; Hutton, A. A.; Palumbo, M. C.; Casaburi, G.; Mitchell, R. D.; Underwood, M. A.; Smilowitz, J. T.; Frese, S. A., Elevated Fecal pH Indicates a Profound Change in the Breastfed Infant Gut Microbiome Due to Reduction of Bifidobacterium over the Past Century. mSphere 2018, 3 (2), e00041-18.
  2. Vatanen, T.; Kostic, A. D.; d’Hennezel, E.; Siljander, H.; Franzosa, E. A.; Yassour, M.; Kolde, R.; Vlamakis, H.; Arthur, T. D.; Hämäläinen, A.-M., Variation in microbiome LPS immunogenicity contributes to autoimmunity in humans. Cell 2016, 165 (4), 842-853.
  3.  Kalliomäki, M.; Carmen Collado, M.; Salminen, S.; Isolauri, E., Early differences in fecal microbiota composition in children may predict overweight–. The American journal of clinical nutrition 2008, 87 (3), 534-538.

  4. Knip, M.; Siljander, H., The role of the intestinal microbiota in type 1 diabetes mellitus. Nature Reviews Endocrinology 2016, 12 (3), 154.

  5.  Arrieta, M.-C.; Stiemsma, L. T.; Dimitriu, P. A.; Thorson, L.; Russell, S.; Yurist-Doutsch, S.; Kuzeljevic, B.; Gold, M. J.; Britton, H. M.; Lefebvre, D. L., Early infancy microbial and metabolic alterations affect risk of childhood asthma. Science translational medicine 2015, 7 (307), 307ra152-307ra152.

  6. Smilowitz, J. T.; Moya, J.; Breck, M. A.; Cook, C.; Fineberg, A.; Angkustsiri, K.; Underwood, M. A., Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial. BMC pediatrics 2017, 17 (1), 133.

  7.  Frese, S. A.; Hutton, A. A.; Contreras, L. N.; Shaw, C. A.; Palumbo, M. C.; Casaburi, G.; Xu, G.; Davis, J. C.; Lebrilla, C. B.; Henrick, B. M., Persistence of Supplemented Bifidobacterium longum subsp. infantis EVC001 in Breastfed Infants. mSphere 2017, 2 (6), e00501-17.