Objective: The aim of the study was to evaluate the effect of infant formula with polydextrose (PDX) and galacto-oligosaccharides (GOS) on fecal microbiota and secretory IgA (sIgA).
Materials and Methods: In the present double-blind, randomized study, term infants received control (Enfamil Lipil) or the same formula with PDX/GOS (4 g/L, 1:1 ratio; PDX/GOS) for 60 days; a reference breast-fed group was included. Formula intake, tolerance, and stool characteristics were collected via electronic diary and analyzed by repeated measures analysis of variance. Anthropometric measurements and stool samples were obtained at baseline and after 30 and 60 days of feeding. Fecal sIgA was measured by enzyme-linked immunosorbent assay and fecal bacteria by fluorescent in situ hybridization and quantitative real-time polymerase chain reaction (qPCR); both were analyzed by Wilcoxon rank sum test.
Results: Two hundred thirty infants completed the study. Infants consuming PDX/GOS had softer stools than control at all times (P < 0.001). Using qPCR, counts in PDX/GOS were closer to the breast-fed group, tended to be higher than control for total bifidobacteria (P = 0.069) and Bifidobacterium longum (P = 0.057) at 30 days, and were significantly higher for total bifidobacteria and B longum at 60 days and B infantis at 30 days (P = 0.002). No significant differences were detected between PDX/GOS and control in changes from baseline to 30 or 60 days for sIgA or total bifidobacteria by fluorescent in situ hybridization or qPCR; however, significantly higher changes from baseline were detected between PDX/GOS and control for B infantis at 30 days and B longum at 60 days (P ≤ 0.035).
Conclusions: Infant formula with PDX/GOS produces soft stools and a bifidogenic effect closer to breast milk than formula without PDX/GOS.
*Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN
†Department of Medical Microbiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
‡Department of Global Scientific Affairs, Mead Johnson Nutrition, Evansville, IN
§Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
||Functional Foods Forum, University of Turku, Turku, Finland.
Address correspondence and reprint requests to Susan H. Mitmesser, PhD, Department of Medical Affairs, Mead Johnson Nutrition, 2400 W Lloyd Expressway, Evansville, IN 47721 (e-mail: email@example.com).
Received 16 June, 2010
Accepted 6 September, 2011
The present study was funded by Mead Johnson Nutrition.
D.M.S., S.H.M., C.L.H., J.D.M., J.A.V., and D.C.W. are employees of Mead Johnson Nutrition. The other authors report no conflicts of interest.
www.clinicaltrials.gov registration number: NCT00503789.