Objectives: Levels of stool fatty acid soaps and beneficial bacteria differ between formula-fed and breast-fed infants; addition of specific formula ingredients may reduce these differences. This study evaluated the effects of a term infant formula containing high sn-2 palmitate term infant formula (sn-2) or an identical formula supplemented with oligofructose (OF) at 2 concentrations (sn-2+3 g/L OF, sn-2+5 g/L OF) on stool composition, stool characteristics, and fecal bifidobacteria.
Methods: Healthy, term formula-fed infants 7 to 14 days old (n = 300) were randomized in a double-blind manner to receive standard formula (control), sn-2, sn-2+3 g/L OF, or sn-2+5 g/L OF for 8 weeks. Human milk (HM)–fed infants (n = 75) were studied in parallel. Stool samples were collected from all subjects at week 8 for fatty acid soaps and mineral content, and from a subset at baseline and week 8 for bifidobacteria. Stool characteristics were assessed via 3-day diary.
Results: The sn-2 group had 46% less stool soap palmitate (P < 0.001) and softer stools than control (20% more mushy soft stools, P = 0.026; 50% fewer formed stools, P = 0.003). Addition of OF resulted in even fewer formed stools versus control (65% fewer for sn-2+3 g/L OF, 79% fewer for sn-2+5 g/L OF), with 5 g/L OF more closely resembling that of HM-fed infants. Both sn-2 (P < 0.05) and sn-2 with OF groups (P < 0.01) had significantly higher fecal bifidobacteria concentrations than control at week 8, not differing from HM-fed infants.
Conclusions: High sn-2-palmitate formulas led to reduced stool soaps, softer stools, and increased bifidobacteria, whereas addition of OF further improved stool consistency. Those modifications brought outcomes in formula-fed infants closer to that in HM-fed infants.
*Research and Development, Nestlé Nutrition, King of Prussia, PA
†Department of Food Science and Human Nutrition, University of Illinois, Urbana
‡Department of Pediatrics, Asian Hospital and Medical Center, Muntinlupa City, Philippines
§Research and Development, Wyeth Nutritionals Ireland, Askeaton
||Medical Affairs Department, Wyeth Philippines Inc, Makati City, Philippines
¶Worldwide Research and Development, Pfizer Inc, Peapack, NJ
#Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.
Address correspondence to Manjiang Yao, MD, PhD, Director, Clinical Science, Nestlé Nutrition, 3000 Horizon Dr, Suite 100, King of Prussia, PA 19406 (e-mail: firstname.lastname@example.org).
www.clinicaltrials.gov registration number: NCT01861600.
This study was sponsored by Wyeth Nutrition, a Nestlé business.
M.Y., M.F., R.N., and J.L. are current employees of Nestlé Nutrition (M.Y., R.N.) and Wyeth Nutrition (M.F., J.L.). K.R., R.Y., L.W., and P.A.D. were employees of Wyeth Nutrition at the time of the study. The other authors report no conflicts of interest.
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Received November 27, 2013
Accepted May 12, 2014