Evidence map›Paper›PMID 41310220›Full record

Trial reportPediatric research2026

L.Fermentum CECT5716 and B.Breve CECT7263 on premature infants morbidities: a randomized clinical trial.

José Antonio Hurtado Suazo, Almudena Alonso Ojembarrena, Tomás Sánchez Tamayo, Estefania Martín Alvarez, Maria Eugenia Saez, Luz Martínez Pardo, Javier Díez Delgado Rubio, Mercedes Granero Asencio, Laura Serrano López, Jose Antonio Maldonado-Lobón and 9 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Pediatric research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Review
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

19 authors.

José Antonio Hurtado SuazoNeonatology Division, Virgen de las Nieves University Hospital, Granada, Spain. jant.hurtado.sspa@juntadeandalucia.es.
Almudena Alonso OjembarrenaNeonatal Intensive Care Unit, Puerta del Mar University Hospital, Cádiz, Spain.
Tomás Sánchez TamayoNeonatology Division, Regional University Hospital, Málaga, Spain.
Estefania Martín AlvarezNeonatology Division, Virgen de las Nieves University Hospital, Granada, Spain.
Maria Eugenia SaezKerry Group, Granada, Spain.
Luz Martínez PardoNeonatology Division, Jaen University Hospital, Jaen, Spain.
Javier Díez Delgado RubioNeonatology Division, Princesa Leonor University Hospital, Almería, Spain.
Mercedes Granero AsencioNeonatology Division, Virgen de Macarena University Hospital, Sevilla, Spain.
Laura Serrano LópezNeonatology Division, Virgen de las Nieves University Hospital, Granada, Spain.
Jose Antonio Maldonado-LobónKerry Group, Granada, Spain.
David Mora NavarroNeonatology Division, Juan Ramón Jiménez University Hospital, Huelva, Spain.
María Teresa de Benito GuerraNeonatology Division, Jerez University Hospital, Cádiz, Spain.
Eva Torres BegaraNeonatology Division, Virgen de Valme University Hospital, Sevilla, Spain.
Juan Antonio Ruiz MorenoNeonatology Division, Costa del Sol Hospital, Marbella, Málaga, Spain.
Carmen Macías DíazNeonatology Division, Virgen del Rocío University Hospital, Sevilla, Spain.
José María Lloreda GarcíaNeonatology Division, Santa Lucía University Hospital, Cartagena, Murcia, Spain.
Manuela Peña CaballeroNeonatology Division, Virgen de las Nieves University Hospital, Granada, Spain.
Mónica OlivaresKerry Group, Granada, Spain.
Ruth Blanco-RojoKerry Group, Granada, Spain. ruth.blanco@kerry.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study examined the effects of two doses of probiotics isolated from human milk on the incidences of necrotizing enterocolitis (NEC) and mortality in preterm infants.

methodsThis multicenter, randomized, double-blind study involved 583 very low birth weight preterm neonates (≤32 6/7 weeks, <1500 g) who started enteral nutrition within 72 h of birth (>5 ml/kg/day) and received either a high-dose (HD, 1 × 10

resultsThe probiotic combination was well tolerated with no adverse effects. The NEC (2.5% vs. 1.3%; p = 0.156) and mortality (3.9% vs. 3.6%; p = 0.685) rates were not significantly different between the groups (HD vs. LD). These rates were lower than those reported in a co-temporal cohort in the region (SEN1500 cohort).

conclusionNo significant differences were found between the HD and the LD of the LC40 and BfM26 combination in the incidence of NEC and all-cause mortality. The incidence rates of death and NEC were lower in this study than in the SEN1500 cohort, suggesting that the low dose may suffice for preterm infants. This study supports the safety and tolerability of these probiotics in preterm infants. IMPACT: The study responds to scientific societies' request for more clinical trials to strengthen the currently low level of evidence on probiotics' safety and benefits for preterm infants. The study presents evidence supporting the safety and the effect of two different doses of a combination of two human milk-derived probiotic strains in preterm infants. The study indicates that a low dose of probiotics may be sufficient to achieve beneficial effects in preterm infants. These findings will inform future research on optimizing probiotic dosing in this population.

Indexed as

Bifidobacterium breveEnterocolitis, NecrotizingInfant, PrematureProbioticsDouble-Blind MethodEnteral NutritionFemaleHumansInfant, NewbornInfant, Very Low Birth WeightMaleMilk, HumanTreatment Outcome

Identifiers

PMID41310220
PMCPMC13524821

What OpenQuestion holds

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Registered trials

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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 OpenQuestion graph.