Randomized Controlled Trial Testing the Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old

Inclusion criteria :

• less then 12 weeks of age
• term infant (≥ 38 weeks gestational age)
• birth weight > 2,500g
• infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment.
• parental motivation to postpone changes in the infant feeding mode, unless necessary

Exclusion criteria:

• birth weight less than 2500 g
• failure to thrive
• chronic illness or major medical problem
• gastrointestinal disease
• cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??)
• use of any antibiotic or probiotic in the week (7 days) prior to enrollment
• use of proton pump inhibitors in the week (7 days) prior to enrollment
• if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrollment
• infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
• change of feeding mode planned by parents during the study period

Randomization and blinding: to be written by the CRO, according to its own procedures.