AND RELEVANCE Although L reuteri may be effective as treatment for crying in exclusively breastfed infants with colic , there is still insufficient evidence to support probiotic use to manage colic , especially in formula-fed infants , or to prevent infant crying .
IMPORTANCE  Excessive infant crying  is common , distressing , but without proven effective prevention or management options .
Probiotics may be a promising solution .
OBJECTIVE To examine whether probiotics are effective in the prevention/management of crying ( " colic " ) in infants 3 months or younger .
An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial.
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 , r and omised controlled trial in which they received experimental ( n 48 ) or st and ard 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
AND RELEVANCE Although L reuteri may be effective as treatment for crying in exclusively breastfed infants with colic , there is still insufficient evidence to support probiotic use to manage colic , especially in formula-fed infants , or to prevent infant crying .
IMPORTANCE  Excessive infant crying  is common , distressing , but without proven effective prevention or management options .
Probiotics may be a promising solution .
OBJECTIVE To examine whether probiotics are effective in the prevention/management of crying ( " colic " ) in infants 3 months or younger .