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Randomized, placebo-controlled trial reveals the impact of dose and timing of Bifidobacterium infantis probiotic supplementation on breastfed infants’ gut microbiome
by
O'Brien, Claire E.
, Frese, Steven A.
, Melnyk, Ryan A.
, Smilowitz, Jennifer T.
, Mitchell, Ryan D.
, Casaburi, Giorgio
, Cernioglo, Karina
, Henrick, Bethany M.
, Damian-Medina, Karla
in
Bifidobacterium infantis
/ Bifidobacterium longum subspecies infantis - physiology
/ Breast Feeding
/ breastfed
/ Clinical Microbiology
/ Dietary Supplements
/ Editor’s Pick
/ Feces - microbiology
/ Female
/ Food Microbiology
/ Gastrointestinal Microbiome - drug effects
/ Gut Microbiota
/ Host-Associated Microbiomes
/ Host-Associated Microbiota
/ Host-Microbiome Interactions
/ Human Microbiota
/ Humans
/ Infant
/ infant gut microbiome
/ Infant Microbiota
/ Male
/ Microbial Ecology and Evolution
/ Microbial Physiology and Genetics
/ Microbiome Applications
/ Microbiome Influence on Development
/ Microbiome Research
/ Placebos - administration & dosage
/ probiotic
/ Probiotics
/ Probiotics - administration & dosage
/ Probiotics and Prebiotics
/ randomized, placebo-controlled trial
/ Research Article
2026
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Randomized, placebo-controlled trial reveals the impact of dose and timing of Bifidobacterium infantis probiotic supplementation on breastfed infants’ gut microbiome
by
O'Brien, Claire E.
, Frese, Steven A.
, Melnyk, Ryan A.
, Smilowitz, Jennifer T.
, Mitchell, Ryan D.
, Casaburi, Giorgio
, Cernioglo, Karina
, Henrick, Bethany M.
, Damian-Medina, Karla
in
Bifidobacterium infantis
/ Bifidobacterium longum subspecies infantis - physiology
/ Breast Feeding
/ breastfed
/ Clinical Microbiology
/ Dietary Supplements
/ Editor’s Pick
/ Feces - microbiology
/ Female
/ Food Microbiology
/ Gastrointestinal Microbiome - drug effects
/ Gut Microbiota
/ Host-Associated Microbiomes
/ Host-Associated Microbiota
/ Host-Microbiome Interactions
/ Human Microbiota
/ Humans
/ Infant
/ infant gut microbiome
/ Infant Microbiota
/ Male
/ Microbial Ecology and Evolution
/ Microbial Physiology and Genetics
/ Microbiome Applications
/ Microbiome Influence on Development
/ Microbiome Research
/ Placebos - administration & dosage
/ probiotic
/ Probiotics
/ Probiotics - administration & dosage
/ Probiotics and Prebiotics
/ randomized, placebo-controlled trial
/ Research Article
2026
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Randomized, placebo-controlled trial reveals the impact of dose and timing of Bifidobacterium infantis probiotic supplementation on breastfed infants’ gut microbiome
by
O'Brien, Claire E.
, Frese, Steven A.
, Melnyk, Ryan A.
, Smilowitz, Jennifer T.
, Mitchell, Ryan D.
, Casaburi, Giorgio
, Cernioglo, Karina
, Henrick, Bethany M.
, Damian-Medina, Karla
in
Bifidobacterium infantis
/ Bifidobacterium longum subspecies infantis - physiology
/ Breast Feeding
/ breastfed
/ Clinical Microbiology
/ Dietary Supplements
/ Editor’s Pick
/ Feces - microbiology
/ Female
/ Food Microbiology
/ Gastrointestinal Microbiome - drug effects
/ Gut Microbiota
/ Host-Associated Microbiomes
/ Host-Associated Microbiota
/ Host-Microbiome Interactions
/ Human Microbiota
/ Humans
/ Infant
/ infant gut microbiome
/ Infant Microbiota
/ Male
/ Microbial Ecology and Evolution
/ Microbial Physiology and Genetics
/ Microbiome Applications
/ Microbiome Influence on Development
/ Microbiome Research
/ Placebos - administration & dosage
/ probiotic
/ Probiotics
/ Probiotics - administration & dosage
/ Probiotics and Prebiotics
/ randomized, placebo-controlled trial
/ Research Article
2026
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Randomized, placebo-controlled trial reveals the impact of dose and timing of Bifidobacterium infantis probiotic supplementation on breastfed infants’ gut microbiome
Journal Article
Randomized, placebo-controlled trial reveals the impact of dose and timing of Bifidobacterium infantis probiotic supplementation on breastfed infants’ gut microbiome
2026
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Overview
This study found that supplementing exclusively breastfed infants with a probiotic, Bifidobacterium infantis EVC001, between 2 and 4 months of age can successfully restore beneficial bacteria in their gut, even after the newborn period. Although previous research showed this effect in newborns, this is the first study to demonstrate that older infants, whose gut microbiomes are typically more stable, can still benefit. The probiotic was effective at all tested doses, with higher levels of B. infantis and overall Bifidobacteriaceae in infants' stool during and even 1 month after supplementation. This study demonstrates that B. infantis can take hold in the gut and potentially improve gut health in older breastfed babies, offering a promising approach to support infant health in settings where beneficial gut bacteria are often missing. This study was registered at clinicaltrials.gov as NCT03476447 .
Publisher
American Society for Microbiology,American Society for Microbiology (ASM)
Subject
/ Bifidobacterium longum subspecies infantis - physiology
/ Female
/ Gastrointestinal Microbiome - drug effects
/ Host-Microbiome Interactions
/ Humans
/ Infant
/ Male
/ Microbial Ecology and Evolution
/ Microbial Physiology and Genetics
/ Microbiome Influence on Development
/ Placebos - administration & dosage
/ Probiotics - administration & dosage
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