In:
Klinische Pädiatrie, Georg Thieme Verlag KG, Vol. 235, No. 04 ( 2023-07), p. 213-220
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.
Type of Medium:
Online Resource
ISSN:
0300-8630
,
1439-3824
Language:
English
Publisher:
Georg Thieme Verlag KG
Publication Date:
2023
detail.hit.zdb_id:
2039110-9
