title: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Proportion of infants colonized with probiotic species was similar with high-dose and standard dose regimes.
authors.affiliation: Division of Neonatology, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Sourabh
authors.initials: S
authors.lastname: Dutta
authors.affiliation: Department of Medical Microbiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Pallab
authors.initials: P
authors.lastname: Ray
authors.affiliation: Division of Neonatology, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Anil
authors.initials: A
authors.lastname: Narang
mesh_terms: D001644:Bifidobacterium / Q000378:metabolism*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005243:Feces / Q000382:microbiology*; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007778:Lactobacillus / Q000378:metabolism*; D008297:Male; D019936:Probiotics / Q000008:administration & dosage* / Q000145:classification*; D016896:Treatment Outcome