Oral probiotics prevent necrotizing enterocolitis in very low birth weight preterm infants: a multicenter, randomized, controlled trial.
OBJECTIVE
The goal was to investigate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis for very low birth weight preterm infants.


METHODS
A prospective, blinded, randomized, multicenter controlled trial was conducted at 7 NICUs in Taiwan, to evaluate the beneficial effects of probiotics in necrotizing enterocolitis among very low birth weight infants (birth weight: <1500 g). Very low birth weight infants who survived to start enteral feeding were eligible and were assigned randomly to 2 groups after parental informed consent was obtained. Infants in the study group were given Bifidobacterium bifidum and Lactobacillus acidophilus, added to breast milk or mixed feeding (breast milk and formula), twice daily for 6 weeks. Infants in the control group were fed with breast milk or mixed feeding. The clinicians caring for the infants were blinded to the group assignment. The primary outcome measurement was death or necrotizing enterocolitis (Bell's stage >or=2).


RESULTS
Four hundred thirty-four infants were enrolled, 217 in the study group and 217 in the control group. The incidence of death or necrotizing enterocolitis (stage >or=2) was significantly lower in the study group (4 of 217 infants vs 20 of 217 infants). The incidence of necrotizing enterocolitis (stage >or=2) was lower in the study group, compared with the control group (4 of 217 infants vs 14 of 217 infants). No adverse effect, such as sepsis, flatulence, or diarrhea, was noted.


CONCLUSIONS
Probiotics, in the form of Bifidobacterium and Lactobacillus, fed enterally to very low birth weight preterm infants for 6 weeks reduced the incidence of death or necrotizing enterocolitis.
Lin
Hung-Chih
HC
Department of Pediatrics and School of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan. d0373@mail.cmuh.org.tw
Hsu
Chyong-Hsin
CH
Chen
Hsiu-Lin
HL
Chung
Mei-Yung
MY
Hsu
Jen-Fu
JF
Lien
Rey-in
RI
Tsao
Lon-Yen
LY
Chen
Chao-Huei
CH
Su
Bai-Horng
BH
D000284:Administration, Oral; D001644:Bifidobacterium; D020345:Enterocolitis, Necrotizing / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D007779:Lactobacillus acidophilus; D008297:Male; D010865:Pilot Projects; D019936:Probiotics / Q000008:administration & dosage*; D011446:Prospective Studies; D016037:Single-Blind Method; D015996:Survival Rate / Q000639:trends; D013624:Taiwan / Q000453:epidemiology; D016896:Treatment Outcome