Journal of Parenteral and Enteral Nutrition Volume 36 Supplement 1 January 2012 106S-117S © 2012 American Society for Parenteral and Enteral Nutrition 10.1177/0148607111430817 http://jpen.sagepub.com hosted at http://online.sagepub.com 106S Clinical Relevancy Statement Breast milk, the ideal source of nutrition for infants, is also a source of secretory immunoglobulin A (IgA), as well as bacte- From the 1 Department of Food Science and Human Nutrition, Division of Nutritional Sciences, University of Illinois, Urbana- Champaign, Illinois; 2 Nestlé Infant Nutrition, Florham Park, New Jersey; 3 Pedia Research, Owensboro, Kentucky; 4 Southwest Children’s Research Associates, P.A., San Antonio, Texas; 5 Scott & White Memorial Hospital, Temple, Texas; 6 Exponent, Inc, Health Sciences Practice, Chicago, Illinois; and 7 Virginia Commonwealth University, Richmond, Virginia. Received for publication September 1, 2011; accepted for pub- lication November 2, 2011. Address correspondence to: Kelly A. Tappenden, PhD, RD, Department of Food Science and Human Nutrition, Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, 443 Bevier Hall, 905 South Goodwin Ave, Urbana, IL 61801; e-mail: tappende@illinois.edu. ria, which enhance both passive and active infant immunity. These benefits are not provided by routine-use infant for- mula. The addition of probiotics to infant formula is reported to increase fecal secretory IgA. This study demonstrates that supplementation of infant formula with Bifidobacterium ani- malis subspecies lactis (Bb12) results in detectable fecal lev- els of Bb12 and increased concentrations of secretory-, anti-rotavirus-specific, and anti-poliovirus-specific IgA. Therefore, including Bb12 in infant formula provides infants a safe, dietary, immune-modulating bacterial experience. Introduction Although it is known that breastfeeding is best, infant formulas are often used to supplement breast milk, and mothers of some infants may choose not to breastfeed. Attempts to optimize infant formula have been under- taken to impart some of the benefits of breast milk to the Background: Addition of probiotics to infant formula may positively affect immune function in nonexclusively breastfed infants. This study aimed to investigate the effect of infant starter formula con- taining the probiotic Bifidobacterium animalis subspecies lactis (Bb12) on intestinal immunity and inflammation. Methods: Six- week-old healthy, full-term infants (n = 172) were enrolled in a prospective, randomized, double-blind, controlled clinical trial with 2 groups studied in parallel to a breastfed comparison group. Formula-fed (FF) infants were randomized to partially hydrolyzed whey formula (CON) or the same formula containing 10 6 colony- forming units (CFU) Bb12/g (PRO) for 6 weeks. Fecal secretory IgA (sIgA), calprotectin, lactate, and stool pH were assessed at baseline, 2 weeks, and 6 weeks. Anti-poliovirus-specific IgA and anti-rotavirus- specific IgA were assessed at 2 and 6 weeks. Results: Among vaginally delivered FF infants, PRO consumption increased (P < .05) fecal sIgA compared to CON. Anti-poliovirus-specific IgA concentration increased (P < .05) in all infants consuming PRO, whereas anti- rotavirus-specific IgA tended to increase (P = .056) with PRO con- sumption in cesarean-delivered infants. Anthropometrics and tolerance did not differ significantly between FF infants. Conclusions: Infants consuming formula with Bb12 produced feces with detect- able presence of Bb12 and augmented sIgA concentration. Furthermore, cesarean-delivered infants consuming Bb12 had heightened immune response, as evidenced by increased anti-rotavi- rus- and anti-poliovirus-specific IgA following immunization. These results demonstrate that negative immune-related effects of not breastfeeding and cesarean delivery can be mitigated by including Bb12 in infant formula, thereby providing infants a safe, dietary, immune-modulating bacterial introduction. (JPEN J Parenter Enteral Nutr. 2012;36:106S-117S) Keywords: infant formula; pediatrics; probiotics Bifidobacterium lactis Bb12 Enhances Intestinal Antibody Response in Formula-Fed Infants: A Randomized, Double-Blind, Controlled Trial Hannah D. Holscher, RD 1 ; Laura A. Czerkies, MS, RD 2 ; Pamela Cekola, RD 2 ; Richard Litov, PhD 3 ; Marshall Benbow, MD 4 ; Sheryl Santema, MD 5 ; Dominik D. Alexander, PhD, MSPH 6 ; Vanessa Perez, PhD, MS 6 ; Shumei Sun, PhD 7 ; José M. Saavedra, MD 2 ; and Kelly A. Tappenden, PhD, RD 1 Financial disclosure: This study was sponsored by Nestlé Infant Nutrition, Florham Park, NJ. The publication of the supplement in which this article appears is sponsored by Nestlé Nutrition Institute. Original Communication at UNIV OF ILLINOIS URBANA on May 22, 2015 pen.sagepub.com Downloaded from