Original ArticleThe ProPre-Save Study: Effects of Probiotics and Prebiotics Alone or Combined on Necrotizing Enterocolitis in Very Low Birth Weight Infants
Section snippets
Methods
The ProPre-Save trial is a multicenter, prospective, randomized, double-blind, randomized controlled trial (RCT) in which the supplementation of VLBW infants with probiotic, prebiotic, or synbiotic was compared with placebo. The trial was conducted from June 2011 to June 2014 at 5 tertiary NICU centers from different geographical regions of Turkey (Dr Sami Ulus Maternity and Children Research and Training Hospital, Ankara; Diyarbakır Maternity and Children Hospital, Diyarbakır; Şevket Yılmaz
Results
There were 677 VLBW infants admitted to the 5 NICUs during the 3-year study period. Of these infants, 277 were excluded. A total of 400 VLBW infants were eligible for the study: 300 were randomly assigned to 1 of the 3 active intervention groups (100 in each group) and 100 to the placebo group (Figure; available at www.jpeds.com).
The maternal and infants demographic characteristics did not differ (Table I). Enteral feeding was initiated at a similar postnatal age in groups. Oral supplementation
Discussion
Bifidobacterium lactis alone or in combination with inulin reduces the incidence of NEC in VLBW infants. The prebiotic alone had no effect in the prevention of NEC. Late-onset infection in the NICU is associated with prolonged hospitalization, morbidity, and mortality. In premature infants hospitalized in NICU, GI colonization with normal bacterial flora (eg, Bifidobacterium spp. and Lactobacillus spp.) is delayed and lacks biodiversity, whereas colonization with potentially pathogenic bacteria
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2022, Clinics in PerinatologyCitation Excerpt :In children, synbiotics decreased weight in obese patients, improved symptoms of atopic dermatitis, and decreased sepsis and NEC rates in patients with congenital heart disease.10,18,19 Four placebo-controlled studies have been reported on the use of synbiotics in preterm infants.46–49 One study that used a combination of the probiotic B lactis and the prebiotic inulin described a lower incidence of NEC and reduced mortality in both the probiotic and synbiotic study arms, but with no beneficial effects observed in infants administered the prebiotic alone.46
The authors declare no conflicts of interest.
Registered with ClinicalTrials.gov: NCT01807858.