Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis

Terminated 57 enrolled Tel-Aviv Sourasky Medical Center

RandomizedParallel-groupQuadruple-blindPrevention

Summary

We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.

Timeline

Start: 2007-06
Primary completion: 2009-07
Completion: 2009-07

Outcome

Missed primary endpoint

Stopped (Enrollment): “Difficulty in recruitment. Mothers of infants preferred to take probiotics bought over-the-counter over the possibility of being in a placebo group”

paper The overall incidence of Bell stage II to III NEC was 12%, with an incidence of 4% in the infants of the probiotic group and 18.2% in the placebo group (p = 0.12), respectively. PMID 23934538 ↗

paper Sepsis and mortality rates were similar. PMID 23934538 ↗

Publications

Benor S, Marom R, Ben Tov A, Armoni Domany K, Zaidenberg-Israeli G, Dollberg S. Probiotic supplementation in mothers of very low birth weight infants. Am J Perinatol. 2014 Jun;31(6):497-504. doi: 10.1055/s-0033-1353490. Epub 2013 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bifidobacteria lactis	Other / unclassified	—	Oral
Subject	Lactobacillus acidophilus	Other / unclassified	—	Oral