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CC BY-NC-ND 4.0 · Klin Padiatr 2023; 235(04): 213-220
DOI: 10.1055/a-1970-4340
Original Article

Potential Benefit of Probiotic E. Coli Nissle in Term Neonates

A Multicentre Randomised Double Blind Controlled TrialPotentieller Nutzen des Probiotikums E. coli Nissle bei NeugeborenenEine multizentrische randomisierte kontrollierte Doppelblindstudie
Dirk Olbertz
1   Department of Neonatology, Klinikum Südstadt Rostock, Rostock, Germany
,
Hans Proquitté
2   Section of Neonatology and Neonatal Intensive Care, Department of Pediatrics, Jena University Hospital, Jena, Germany
,
Ludwig Patzer
3   Pediatrics, Children’s Hospital St. Elisabeth and St. Barbara, Halle/Saale, Germany
,
Thomas Erler 
4   Department of Pediatrics, Klinikum Westbrandenburg, Potsdam, Germany
,
Alexsandra Mikolajczak
5   Department of Neonatology, University Clinical Centre of Warsaw Medical University, Warsaw, Poland
,
Iwona Sadowska-Krawczenko
6   Department of Neonatology, Nicolaus Copernicus University in Toruń Ludwik Rydygier Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland
,
Corinna Wolff
7   Department of Clinical Research, Ardeypharm GmbH, Herdecke, Germany
,
Michael Radke
8   Department of Pediatrics, University Hospital Rostock, Rostock, Germany
› Author Affiliations Funding Information The study was funded by Ardeypharm, Herdecke, Germany (provision of Mutaflor and placebo suspension; reimbursement of studyrelated expenditure).
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Correction: Potential Benefit of Probiotic E. Coli Nissle in Term NeonatesKlin Padiatr 2023; 235(04): e17-e17
DOI: 10.1055/a-1991-9977

Abstract

Background Probiotics 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 methods This 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.

Results Incidence 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.

Conclusions A 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.

Zusammenfassung

Hintergrund Probiotika werden oftmals als Immunstimulans gewertet. In dieser Studie wurde untersucht, ob sich für reife Neugeborene durch die perorale Verabreichung von Escherichia coli Nissle 1917 die Zahl der Infektionen, ihre Dauer und Schwere in den ersten 24 Monaten nach Geburt verringert.

Probanden und Methoden 567 gesunde Neugeborene aus vier deutschen und zwei polnischen Studienzentren wurden in diese prospektive, konfirmatorische, randomisierte, doppelblinde und Plazebo-kontrollierte Studie eingeschlossen. Neugeborene erhielten 10e8 lebende E. coli Nissle (n=283) oder Plazebo (n=284) täglich in der ersten Woche und jeden zweiten Tag in Woche 2 und 3. Nach 6 und 12 Monaten fanden zusätzliche Verabreichungen an zehn aufeinanderfolgenden Tagen statt. Die Wirksamkeit insgesamt wurde anhand der Zahl der Infektionen im Beobachtungszeitraum beurteilt.

Ergebnisse Nach 24 Monaten bestand zwischen den Gruppen kein statistisch signifikanter Unterschied in den Inzidenzraten der Infektionen, Dauer oder Schwere der Infektionen. Post-hoc Analysen ergaben allerdings einen kurzfristigen Nutzen von E. coli Nissle vier Wochen nach Beginn der Therapie, der nach acht Wochen nachgelassen hatte. E. coli Nissle war sicher und wurde gut toleriert.

Schlussfolgerungen Es konnte kein gegen Infektionen schützender Langzeiteffekt nach intestinaler Besiedlung mit E. coli Nissle für den gesundenen Neugeborenen gezeigt werden. Zusätzliche Studien sind nötig, um die vorübergehende, jedoch klinisch signifikante Rolle des Probiotikums in den ersten vier Wochen nach Entbindung zu bestätigen.

Keywords

neonates - E. coli Nissle - probiotics - infections

Schlüsselwörter

Neugeborene - E. coli Nissle - Probiotika - Infektionen

Supplementary Material



Publication History

Article published online:
29 November 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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