This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
Aged between 3-12 weeks at screening.
Gestational age 37+0 weeks - 42+0 weeks at birth.
Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
Parents/caregivers/legal guardians are >18 years.
Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis).
Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container > 12x in breastfed and >5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/ legal guardians.
Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
Parallel
L. reuteri
Dietary supplementSupplementation with drops containing L. reuteri once daily for 21 consecutive days
Placebo
Dietary supplementSupplementation with identical drops without L. reuteri once daily for 21 consecutive days
Crying and fussing time
Change in mean crying and fussing time as assessed by the Baby's Day Diary
Crying and fussing time
Change in mean crying and fussing time as assessed by the Baby's Day Diary
Number of responders
Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline
Family Quality of Life
Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score
Sleeping time
Change in mean sleeping time as assessed by Baby´s Day Diary
