Evidence map›Paper›PMID 36446590›Full record

Trial reportKlinische Padiatrie2023

Potential Benefit of Probiotic E. Coli Nissle in Term Neonates.

Dirk Olbertz, Hans Proquitté, Ludwig Patzer, Thomas Erler, Alexsandra Mikolajczak, Iwona Sadowska-Krawczenko, Corinna Wolff, Michael Radke

Erratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Klinische Padiatrie, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 37% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 2 countries.

Dirk OlbertzDepartment of Neonatology, Klinikum Südstadt Rostock, Rostock, Germany.
Hans ProquittéSection of Neonatology and Neonatal Intensive Care, Department of Pediatrics, Jena University Hospital, Jena, Germany.
Ludwig PatzerPediatrics, Children's Hospital St. Elisabeth and St. Barbara, Halle/Saale, Germany.
Thomas ErlerDepartment of Pediatrics, Klinikum Westbrandenburg, Potsdam, Germany.ORCID 0000-0002-5752-4724
Alexsandra MikolajczakDepartment of Neonatology, University Clinical Centre of Warsaw Medical University, Warsaw, Poland.
Iwona Sadowska-KrawczenkoDepartment of Neonatology, Nicolaus Copernicus University in Toruń Ludwik Rydygier Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland.
Corinna WolffDepartment of Clinical Research, Ardeypharm GmbH, Herdecke, Germany.
Michael RadkeDepartment of Pediatrics, University Hospital Rostock, Rostock, Germany.
Ardeypharm (Germany) · DEJena University Hospital · DEKlinikum Südstadt Rostock · DEKrankenhaus St. Elisabeth und St. Barbara · DEMedical University of Warsaw · PLNicolaus Copernicus University · PLUniversity of Rostock · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProbiotics are often viewed as an immunity enhancing agent. The objective of this study was to investigate whether oral administration of Escherichia coli Nissle 1917 reduces the number of infections, their duration, and severity in the first 24 months after parturition in healthy neonates. SUBJECTS AND

methodsThis prospective, confirmatory, randomised, double-blind, placebo-controlled study enrolled 567 healthy neonates from four German and two Polish sites. Neonates received 10e8 viable E. coli Nissle (n=283) or placebo (n=284) daily in the first week and every second day in week 2 and 3. After 6 and 12 months, the subjects received additional instillations on ten subsequent days. The overall efficacy was assessed by the number of infections per observation period.

resultsIncidence rates of infection, infection duration and severity showed no statistically significant difference between groups after 24 months. Post-hoc analyses, however, revealed a short-term benefit of E. coli Nissle four weeks after treatment start which became less pronounced after eight weeks. E. coli Nissle was safe and well tolerated.

conclusionsA long-term effect after colonising the healthy neonate´s gut with E. coli Nissle to protect against infections could not be shown. Additional studies are needed to confirm a transitory, yet clinically significant role of probiotics in the first four weeks after parturition.

Indexed as

Escherichia coliProbioticsAdministration, OralDouble-Blind MethodHumansInfant, NewbornProspective Studies

Identifiers

PMID36446590
PMCPMC10328724
OpenAlexW4310345673

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.