Probiotic Supplementation in Extremely Preterm Infants in Scandinavia

NARecruitingINTERVENTIONAL
Enrollment

1,600

Participants

Timeline

Start Date

December 16, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2026

Conditions
Necrotizing EnterocolitisDeathSepsis NewbornFeeding Disorder NeonatalGrowth Acceleration
Interventions
DIETARY_SUPPLEMENT

ProPrems

The intervention product, commercially known as ProPrems®, is a combination of (one billion freeze-dried bacteria per 0.5 g in a maltodextrin base powder: Bifidobacterium infantis Bb-02 (DSM 33361) 300 million, Bifidobacterium lactis (BB-12®) 350 million, and Streptococcus thermophilus (TH-4®) 350 million will be given daily once to eligable infants born extremly preterm (\<28weeks of gestation) once they tolerate 3ml of enterla feeds until the age of 34 weeks of gestation.

Trial Locations (1)

17176

RECRUITING

Karolinska University Hospital, Solna

All Listed Sponsors
lead

Region Stockholm

OTHER_GOV