title: An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial.
abstract: 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.
authors.affiliation: Department of Neonatal Medicine, Nantes University Hospital, Boulevard Jean Monet, 44000 Nantes, France. jcroze@chu-nantes.fr
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Rozé
authors.forename: Sébastien
authors.initials: S
authors.lastname: Barbarot
authors.forename: Marie-José
authors.initials: MJ
authors.lastname: Butel
authors.forename: Nathalie
authors.initials: N
authors.lastname: Kapel
authors.forename: Anne-Judith
authors.initials: AJ
authors.lastname: Waligora-Dupriet
authors.forename: Inès
authors.initials: I
authors.lastname: De Montgolfier
authors.forename: Magali
authors.initials: M
authors.lastname: Leblanc
authors.forename: Nathalie
authors.initials: N
authors.lastname: Godon
authors.forename: Pascale
authors.initials: P
authors.lastname: Soulaines
authors.forename: Dominique
authors.initials: D
authors.lastname: Darmaun
authors.forename: Montserrat
authors.initials: M
authors.lastname: Rivero
authors.forename: Christophe
authors.initials: C
authors.lastname: Dupont
mesh_terms: D001644:Bifidobacterium / Q000254:growth & development / Q000276:immunology / Q000302:isolation & purification; D002657:Child Development; D015169:Colony Count, Microbial; D003876:Dermatitis, Atopic / Q000276:immunology / Q000382:microbiology / Q000503:physiopathology / Q000517:prevention & control*; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D005260:Female; D005602:France; D041981:Gastrointestinal Tract / Q000276:immunology / Q000382:microbiology; D006801:Humans; D007071:Immunoglobulin A, Secretory / Q000032:analysis; D018730:Infant Behavior; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D057194:Intention to Treat Analysis; D007768:Lactalbumin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D052201:Lacticaseibacillus rhamnosus / Q000254:growth & development / Q000276:immunology / Q000302:isolation & purification; D008297:Male; D012720:Severity of Illness Index; D058616:Synbiotics / Q000009:adverse effects; D015430:Weight Gain
chemical_list: D007071:Immunoglobulin A, Secretory; D007768:Lactalbumin