LONG TERM CONSUMPTION OF INFANT FORMULAS WITH LIVE PROBIOTIC BACTERIA: SAFETY AND TOLERANCE

Abstract

84 Safety and tolerance of chronic consumption of feeding with live probiotics in infants has not been well documented. We carried out a prospective double blind study in healthy free-living infants attending day care centers. 131 infants were randomized to receive standard milk based formula (Nestlé, USA) with: Bifidobacteria (B), 108 CFU/g and S. thermophilus (ST), 107 CFU/g (High supplement -HS); or B, 107 CFU/g and ST, 107 CFU/g (Low supplement - LS); or formula with no supplement (placebo - P). Only exclusion criteria were breast feeding and history of milk allergy. Standardized weight and length were obtained monthly. Data on formula intake, GI tolerance, and general health indicators were collected by weekly phone call and visits to day care centers. Results: 119 infants (39 on HS, 40 on LS and 40 on P) were enrolled at 6.8 ± 2.5 mo. of age and followed for a total of 68.1 subject-years. 12 subjects consuming formula for < 2 weeks were excluded from analysis. Average consumption at 3 and 12 mo. of age provided 104 and 45.3 Kcal/kg/d respectively. There were no differences in age, gender, formula consumption, or length of study between groups. 9 infants were withdrawn by their parents for perceived effects related to the formula (6 for diarrhea and/or vomiting, 1 constipation, 1 otitis media, 1 rash constipation, 1 otitis media, 1 rash). (Table) No statistical differences were found in these or other health indicators. Conclusions: Long term consumption of these live probiotic containing products by infants, as their sole formula, was well tolerated, safe, and resulted in adequate growth.TABLE