PRiming IMmunity At the
beginning of Life



PRiming IMmunity At the beginning of Life


Project 1

PRIMAL Clinical Study

Efficacy of probiotics to prevent gut dysbiosis in preterm infants between 28+0 and 32+6 weeks gestational age: A randomized, placebo-controlled, double-blind, multicentral clinical trial

Project Summary

Aim: Gut dysbiosis is associated with acute and long-term health problems. Probiotics are widely used to prevent dysbiosis in extremely preterm infants. Yet, the evidence from studies is inconclusive and focused on short term effects. We aim to define the potential of probiotics for modulating both the intestinal microbiome and the developing immune system in preterm infants.

Design: The multi-center, double-blind, placebo-controlled PRIMAL Clinical Study aims to determine, whether Bifidobacterium/Lactobacillus acidophilus probiotics reduce the risk for gut dysbiosis in preterm infants (gestational age between 28+0 and 32+6 weeks) at 28 days and 12 months of life. This vulnerable population is frequently exposed to putative disturbances of host-microbiome interaction and observed under controlled conditions. Microbiome composition will be assessed by high-resolution microbiome analysis. Several aspects of antimicrobial immunity will be studied in blood samples obtained in the neonatal period and at 12 months of life.

Expected outcome: We expect probiotics to ameliorate gut dysbiosis, in particular in infants exposed to antibiotics, where the risk is particularly high. This trial is designed to derive profound new evidence, to clarify efficacy and mechanisms of probiotics in preventing long-term health problems of preterm infants, i.e. infections and growth failure.



Leiter der PRIMAL-Klinischen Studie

Prof. Dr. med. Christoph Härtel

Direktor der Kinderklinik und Poliklinik
Universitätsklinikum Würzburg
Joseph-Schneider-Str. 2
D-97080 Würzburg

E-Mail: Haertel_C1@ukw.de
Telefon: +49 (0) 451 500 42811
Telefax: +49 (0) 451 500 42804