Breast-feeding induces a gut microbiota rich in bifidobacteria, whereas formula-fed babies have a more diverse colonization. This ecosystem contributes to the development of the immune response and the lower incidence of diarrhea and allergy in breast-fed infants. This randomized double-blind controlled trial aimed to evaluate the bifidogenic effect of a mainly whey protein study formula low in phosphate and protein, allowing a composition closer to that of human milk.
One hundred ninety healthy infants exclusively received study formula with or without Bifidobacterium longum (BL999), or a control formula for up to 4 months. Breast-fed infants served as a reference population. Stool samples collected at 2 months of age were analyzed for bacterial counts (log colony-forming unit [CFU]/g).
Bifidobacteria counts were significantly higher in infants receiving the study formula alone (10.0[0.8], P < 0.0001, median [interquartile range]) or with BL999 (9.8[1.4], P < 0.01) than control (9.2[3.5]), and were similar to breast-fed infants (10.1[0.4], P > 0.05). The difference between the 2 study groups was 0.16 log CFU/g (90% confidence interval [CI] [0–0.4]), within the predefined equivalence margin. Microbiota profile, as a percentage of total bacteria counts, showed about 50% Bifidobacteria, 8% Enterobacteria, and <10% Clostridia in study formulae and breast-fed infants versus 22%, 13%, and 19% in controls, respectively. There were no significant differences in growth measurements, digestive tolerance, and adverse events between groups.
This study showed that infant formula closer resembling human milk was more bifidogenic than the control formula and led to a microbiota profile similar to that for breast-fed infants.
*Neonatology Department, France
†Biology Laboratory, Maternité Régionale Universitaire, Nancy, France
‡Nestlé Research Center, Switzerland
§Nestlé Nutrition, Nestec Ltd, Vevey, Switzerland.
Received 2 November, 2010
Accepted 13 January, 2011
Address correspondence and reprint requests to Prof Jean-Michel Hascoët, Department of Neonatology-Maternité Régionale Universitaire, 10 Rue du Dr Heydenreich, 54042 Nancy, France (e-mail: email@example.com).
This study was sponsored by Nestlé Nutrition, Nestec Ltd (Vevey, Switzerland).
P.G.S. is an employee of Nestlé Nutrition, Nestec Ltd.
The other authors report no conflicts of interest.