Comparison of stool colonization in premature infants by three dose regimes of a probiotic combination: a randomized controlled trial

Abstract

Objective: To compare stool colonization among premature infants receiving high-dose probiotics versus standard dose.

Study design: This blinded, randomized, placebo-controlled trial was conducted in a Level III neonatal unit. Eligibility criteria were gestational age 27-33 weeks, age < 96 hours, tolerating milk ≥ 15 mL/kg/day and availability for follow-up. Gastro-intestinal/life-threatening malformations and necrotizing enterocolitis/sepsis were exclusions. A total of 149 subjects were randomly allocated to groups A through D (received 12-hourly probiotic supplements of 10(10) cells for 21 days, 10(10) cells for 14 days, 10(9) cells for 21 days and placebo, respectively). Key outcome was stool colonization by a probiotic organism at 28 days.

Results: Colonization with Lactobacillus and Bifidobacterium was significantly higher in groups A, B, and C versus placebo respectively, but groups A through C did not differ from each other. There were trends toward more colony forming unit (cfu) of Lactobacillus and Bifidobacterium per milliliter of stool in group A versus B and B versus C. Groups A and B and spontaneous preterm labor (SPL) independently predicted high Lactobacillus counts on day 28; groups A, B, and C and SPL predicted high Bifidobacterium counts.

Conclusion: Proportion of infants colonized with probiotic species was similar with high-dose and standard dose regimes.