Evidence map›Paper›PMID 24594833›Full record

Trial reportPloS one2014

Effect of Bifidobacterium breve M-16V supplementation on fecal bifidobacteria in preterm neonates--a randomised double blind placebo controlled trial.

Sanjay Patole, Anthony D Keil, Annie Chang, Elizabeth Nathan, Dorota Doherty, Karen Simmer, Meera Esvaran, Patricia Conway

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 22 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 22 pooled it
9.1field-weighted citation impact, top 1% of its field
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

66 citing papers in PubMed, 22 syntheses or guidelines pooled it, 122 citations in OpenAlex.

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  8. Probiotic sepsis in preterm neonates-a systematic review.European journal of pediatrics · 2022
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  9. [Efficacy of probiotics in preventing late-onset sepsis in very low birth weight infants: a Meta analysis].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2021
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6 more citing papers are in PubMed but not listed here.

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

8 authors at 3 institutions in 1 country.

Sanjay PatoleDepartment of Neonatal Paediatrics, KEM Hospital for Women, Perth, Australia; Centre for Neonatal Research and Education, University of Western Australia, Perth, Australia.
Anthony D KeilPathWest Laboratory Medicine WA, KEM Hospital for Women, Perth, Australia.
Annie ChangDepartment of Neonatal Paediatrics, KEM Hospital for Women, Perth, Australia.
Elizabeth NathanWomen and Infants Research Foundation, KEM Hospital for Women, Perth, Australia.
Dorota DohertyWomen and Infants Research Foundation, KEM Hospital for Women, Perth, Australia; School of Women's and Infants' Health, University of New South Wales, Sydney, Australia.
Karen SimmerDepartment of Neonatal Paediatrics, KEM Hospital for Women, Perth, Australia; Centre for Neonatal Research and Education, University of Western Australia, Perth, Australia.
Meera EsvaranUniversity of New South Wales, Sydney, Australia.
Patricia ConwayUniversity of New South Wales, Sydney, Australia.
UNSW Sydney · AUUniversity of Western Australia · AUWomen and Infants Research Foundation · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProbiotic supplementation significantly reduces the risk of necrotising enterocolitis (NEC) and all cause mortality in preterm neonates. Independent quality assessment is important before introducing routine probiotic supplementation in this cohort.

aimTo assess product quality, and confirm that Bifidobacterium breve (B. breve) M-16V supplementation will increase fecal B. breve counts without adverse effects. METHODS AND

participantsStrain identity (16S rRNA gene sequencing), viability over 2 year shelf-life were confirmed, and microbial contamination of the product was ruled out. In a controlled trial preterm neonates (Gestation <33 weeks) ready to commence or on feeds for <12 hours were randomly allocated to either B. breve M-16V (3×109 cfu/day) or placebo (dextrin) supplementation until the corrected age 37 weeks. Stool samples were collected before (S1) and after 3 weeks of supplementation (S2) for studying fecal B. breve levels using quantitative PCR (Primary outcome). Secondary outcomes included total fecal bifidobacteria and NEC≥Stage II. Categorical and continuous outcomes were analysed using Chi-square and Mann-Whitney tests, and McNemar and Wilcoxon signed-rank tests for paired comparisons.

resultsA total of 159 neonates (Probiotic: 79, Placebo: 80) were enrolled. Maternal and neonatal demographic characteristics were comparable between the groups. The proportion of neonates with detectable B. breve increased significantly post intervention: Placebo: [S1:2/66 (3%), S2: 25/66 (38%), p<0.001] Probiotic: [S1: 29/74 (40%), S2: 67/74 (91%), p<0.001]. Median S1 B. breve counts in both groups were below detection (<4.7 log cells x g(-1)), increasing significantly in S2 for the probiotic group (log 8.6) while remaining <4.7 log in the control group (p<0.001). There were no adverse effects including probiotic sepsis and no deaths. NEC≥Stage II occurred in only 1 neonate (placebo group).

conclusionB. breve M-16V is a suitable probiotic strain for routine use in preterm neonates.

trial registrationAustralia New Zealand Clinical Trial Registry ACTRN 12609000374268.

Indexed as

BifidobacteriumInfant, PrematureProbioticsBase SequenceDNA, BacterialDNA PrimersEnterocolitis, NecrotizingFecesHumansInfant, NewbornInfant, Newborn, DiseasesPolymerase Chain ReactionTreatment OutcomeDNA, BacterialDNA Primers

Identifiers

PMID24594833
PMCPMC3940439
OpenAlexW2066153187

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.