title: A pilot study of Bifidobacterium breve in neonates undergoing surgery for congenital heart disease.
abstract: BACKGROUND
  Probiotics have currently been widely used in patients undergoing various types of surgeries and improved their clinical outcomes, while data in pediatric cardiac surgery have been lacking. We investigated the safety and effects on the intestinal microbiota of the probiotic Bifidobacterium breve in neonates undergoing surgery for congenital heart disease.
  
  
  METHODS
  This pilot, randomized study was performed in a single-center, university hospital-based pediatric intensive care unit (PICU). Twenty-one neonates undergoing surgery for congenital heart disease at >7 days after birth were randomly allocated to two groups: group A received 3 × 10(9) colony-forming units (CFU)/day of enteral B. breve strain Yakult (BBG-01), which was started 1 week before and terminated 1 week after surgery (n = 10), and group B did not receive BBG-01 (n = 11).
  
  
  RESULTS
  The characteristics of the patients were similar in both groups. The postoperative days until fulfillment of the criteria for discharge from the PICU tended to be fewer in group A (8 [7-8] days) than in group B (9 [8-14] days) (p = 0.10). Likewise, the postoperative days to enteral nutrition or achievement of caloric goal tended to be fewer in group A than in group B. The Bifidobacterium in fecal samples after initiating BBG-01 in group A were significantly higher in number than that in group B. Enterobacteriaceae were significantly fewer in group A than in group B immediately (7.0 [3.9-7.7] vs. 8.5 [8.0-9.1] log10 cells/g) and 1 week (7.7 [7.0-8.1] vs. 9.3 [8.6-9.5] log10 cells/g) after surgery (p < 0.05 for both comparisons). The number of Pseudomonas after 1 week was significantly lower in group A than in group B (p = 0.04). The concentrations of total organic and acetic acids were also significantly higher in group A than in group B. The postoperative course was uncomplicated and all neonates were discharged alive from the PICU.
  
  
  CONCLUSIONS
  The perioperative administration of a probiotic to neonates undergoing surgery for congenital heart disease was safe and significantly improved their intestinal environment. The positive effects of this treatment on clinically significant outcomes remain to be investigated.
authors.affiliation: Department of Anesthesiology, Shimada Hospital, Osaka 583-0875, Japan.|Department of Anesthesiology and Intensive Care, Postgraduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.
authors.forename: Takako
authors.initials: T
authors.lastname: Umenai
authors.affiliation: Department of Anesthesiology and Intensive Care, Postgraduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.|Department of Emergency and Critical Care Medicine, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Shime
authors.affiliation: Yakult Central Institute for Microbiological Research, Tokyo 186-8650, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Asahara
authors.affiliation: Yakult Central Institute for Microbiological Research, Tokyo 186-8650, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Nomoto
authors.affiliation: Department of Pediatric Cardiology and Nephrology, Postgraduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Itoi
keywords: Congenital heart surgery; Intestinal microbiota; Neonates; Probiotics