ABSTRACT: Healthy 9- to 48-month-old children (n = 133) were randomized to receive a cow's-milk–based follow-on formula (control) or the same formula with polydextrose and galactooligosaccharides (PDX/GOS) for 108 days. Pediatricians assessed diarrheal disease, stool pattern, acute respiratory infection, systemic antibiotic use, and growth. The 2 groups had similar weight-for-length/height z score and similar odds of having diarrheal disease, acute respiratory infection, and systemic antibiotic use; however, PDX/GOS had greater odds of increased defecation than control (P ≤ 0.01). Addition of PDX and GOS to a follow-on formula was well tolerated and induced a pattern of more frequent and softer stools in toddlers.
*Department of Pediatrics, Fima Lifshitz Research Center, University Hospital Complex Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil
†Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
‡Department of Clinical Research, Medical Affairs, Mead Johnson Nutrition, Evansville, IN.
Address correspondence and reprint requests to Susan H. Mitmesser, PhD, Department of Clinical Research, Medical Affairs, Mead Johnson Nutrition, 2400 West Lloyd Expressway, Evansville, IN 47721 (e-mail: firstname.lastname@example.org).
Received 4 March, 2011
Accepted 6 September, 2011
www.clinicaltrials.gov registration number: NCT01177605.
The present study was supported by Mead Johnson Nutrition.
The authors report no conflicts of interest.