Evidence map›Paper›PMID 41427732›Full record

Trial reportmSphere2026

Randomized, placebo-controlled trial reveals the impact of dose and timing of

Claire E O'Brien, Steven A Frese, Karina Cernioglo, Karla Damian-Medina, Ryan D Mitchell, Giorgio Casaburi, Ryan A Melnyk, Bethany M Henrick, Jennifer T Smilowitz

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in mSphere, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03476447 (Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03476447 nacompletednot on this map

Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants (The REMEDI Study)

TypeinterventionalSponsorEvolve BioSystems, Inc.Ran2018 to 2019Enrolled40ConditionsGut MicrobiomeArmsB. infantis EVC001, Lactose
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Immune development in early life.Nature immunology · 2026
    Review
  3. Review
  4. mSphere · 2026
    Article
4 · The record

Corrections and comments

  • Commented on by
    2026
5 · Who and what money

Authors and funding

9 authors.

Claire E O'Brien *Health and Environmental Sciences Institute, Washington, DC, USA.
Steven A Frese *Department of Nutrition, University of Nevada, Reno, Nevada, USA.ORCID 0000-0003-2053-5830
Karina CerniogloDepartment of Nutrition, University of California Davis, Davis, California, USA.
Karla Damian-MedinaPumpKin Baby Inc., Princeton, New Jersey, USA.
Ryan D MitchellInnerPlant Inc., Davis, California, USA.
Giorgio CasaburiExagen, Inc., Vista, California, USA.
Ryan A MelnykLawrence Berkeley National Laboratory, Berkeley, California, USA.
Bethany M HenrickDepartment of Food Science and Technology, University of Nebraska, Lincoln, Nebraska, USA.
Jennifer T SmilowitzDepartment of Nutrition, University of California Davis, Davis, California, USA.ORCID 0000-0003-1165-1944

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A dysfunctional gut microbiome has become increasingly common in infants born in high-income countries as IMPORTANCE: 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 CLINICAL TRIALS: This study was registered at clinicaltrials.gov as NCT03476447.

Indexed as

Bifidobacterium longum subspecies infantisBreast FeedingGastrointestinal MicrobiomeProbioticsDietary SupplementsFecesFemaleHumansInfantMalePlacebosPlacebosBifidobacterium infantisbreastfedinfant gut microbiomeprobioticrandomized, placebo-controlled trial

Identifiers

PMID41427732
PMCPMC12838401

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.