British Journal of Nutrition

Nutritional Immunology

An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial

Jean-Christophe Rozéa1a2a3 c1, Sébastien Barbarota4, Marie-José Butela5, Nathalie Kapela5, Anne-Judith Waligora-Duprieta5, Inès De Montgolfiera6, Magali Leblanca7, Nathalie Godona1, Pascale Soulainesa8, Dominique Darmauna3, Montserrat Riveroa9 and Christophe Duponta8

a1 Department of Neonatal Medicine, Nantes University Hospital, Boulevard Jean Monet, 44000 Nantes, France

a2 INSERM, CIC004, Nantes University Hospital, Nantes, France

a3 INRA UMR 1280, Physiologie des Adaptations Nutritionnelles, INRA and University of Nantes, Human Nutrition Research Centre (CRNH), Nantes, France

a4 Department of Dermatology, CHU Hôtel-Dieu, Nantes, France

a5 EA 4065, Ecosystème Intestinal, Probiotiques, Antibiotiques, Université Paris Descartes, Paris, France

a6 Department of Neonatal Medicine, Trousseau Hospital, Paris, France

a7 Department of Neonatal Medicine, Angers University Hospital, Angers, France

a8 Department of Paediatric Gastroenterology and Nutrition, Necker-Enfants Malades Hospital, Paris, France

a9 Research and Development Department, Ordesa Group, Barcelona, Spain


The aim of the present study was to evaluate the safety, tolerance and preventive effect on atopic dermatitis of an experimental α-lactalbumin-enriched and symbiotic-supplemented infant formula. A total of ninety-seven non-breastfed term neonates were enrolled into a double-blind, multicentre, randomised controlled trial in which they received experimental (n 48) or standard formula (n 49) for 6 months. The primary outcome was weight at 6 months of age. Secondary outcomes were gastrointestinal tolerance and manifestation of atopic dermatitis. Faecal secretory IgA (SIgA) concentration and microbiota composition of forty-three infants were analysed at 1 and 6 months. Growth was similar in both groups. At 1 month, compared to those in the control group, infants in the experimental group exhibited less crying or agitation, and more quiet behaviour (P = 0·03). At 6 months, atopic dermatitis was less frequently observed in the experimental group (P < 0·05). Decrease of faecal SIgA concentration between 1 and 6 months was mainly observed in the control group. This decrease was significantly associated with atopic dermatitis (P < 0·014) and negatively correlated to the level of colonisation by bifidobacteria (P < 0·005). In conclusion, compared to the control formula, the experimental formula guaranteed a similar growth, was better tolerated at 1 month and had a protective effect against the development of atopic dermatitis.

(Received April 01 2011)

(Revised July 27 2011)

(Accepted July 27 2011)

(Online publication November 14 2011)


c1 Corresponding author: Professor J.-C. Rozé, fax +33 240 083 556, email


Abbreviations: CFU, colony-forming unit; SIgA, secretory IgA