Evidence map›Paper›PMID 41721054›Full record

ArticlePediatric research2026

Live biotherapeutic product IBP-9414 (L. reuteri) in very low birth weight infants: the Connection Study.

Josef Neu, Teresa Del Moral, Scott O Guthrie, Mark L Hudak, Flavia Indrio, Jae H Kim, Anders Kronström, Camilia R Martin, Neena Modi, Jonas Rastad and 6 more

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Article in Pediatric research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Josef NeuUniversity of Florida College of Medicine, Gainesville, FL, USA. neuj@peds.ufl.edu.
Teresa Del MoralUniversity of Miami, Miami, FL, USA.
Scott O GuthrieVanderbilt University School of Medicine, Nashville, TN, USA.
Mark L HudakUniversity of Florida College of Medicine, Jacksonville, FL, USA.
Flavia IndrioUniversity of Salento, Lecce, Italy.
Jae H KimCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Anders KronströmInfant Bacterial Therapeutics AB, Stockholm, Sweden.
Camilia R MartinWeill Cornell Medicine, New York City, NY, USA.
Neena ModiImperial College London, London, UK.
Jonas RastadInfant Bacterial Therapeutics AB, Stockholm, Sweden.
Thomas J SchnitzerNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Rachana SinghTufts University School of Medicine, Boston, MA, USA.
Staffan StrömbergInfant Bacterial Therapeutics AB, Stockholm, Sweden.
Hania SzajewskaMedical University of Warsaw, Warsaw, Poland.
Marcus ThuressonInfant Bacterial Therapeutics AB, Stockholm, Sweden.
Michael CaplanEndeavor Health NorthShore Hospitals, Evanston, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVery low birth weight (VLBW) infants experience high rates of serious intestinal health outcomes, including death. The Connection Study evaluated the efficacy and safety of the live biotherapeutic product IBP-9414 (L. reuteri) versus placebo in necrotizing enterocolitis (NEC), sustained feeding tolerance (SFT), and all-cause mortality in this population.

methodsIn this prospective, double-blind phase 3 trial, 2158 VLBW infants were randomized 1:1 to IBP-9414 or placebo within 48 hours of birth, with daily dosing until 34

resultsIBP-9414 treatment compared with placebo did not result in statistically significant reductions in the primary endpoints, NEC incidence (relative risk [RR]: 0.85, p > 0.05) or time to SFT (hazard ratio: 1.10, p > 0.05). However, there was a reduction in all-cause mortality with IBP-9414 treatment, with mortality incidences of 6.2% in the IBP-9414 group versus 8.5% in the placebo group (RR: 0.73, p = 0.036). Adverse event rates were similar between the groups. There was no evidence of IBP-9414 in any blood culture.

conclusionsIBP-9414 treatment was safe and reduced mortality compared with placebo in vulnerable VLBW infants. IMPACT: The Connection Study provides evidence that the live biotherapeutic product IBP-9414 (L. reuteri) treatment was safe and reduced both mortality and surgically-confirmed  necrotizing enterocolitis (NEC) in vulnerable very low birth weight (VLBW) infants. The Connection Study findings support the use of IBP-9414 in VLBW infants and its potential to safely improve their intestinal mortality and morbidity.

Identifiers

PMID41721054

What Socratic holds

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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 Socratic graph.