Clinical Research Directory

Inclusion Criteria: * Gestational age of minimum 37 weeks. * Birthweight of minimum 2500 g (5.5 lb.). * Age of greater than 3 weeks and less than 12 weeks at enrolment. * Confirmed Infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviour diary recording \>3 hours of crying in a 24-hour period (eDiary App completed daily during run-in period \& for duration of study). * Participant Informed Consent form signed by parent or legal guardian. * Infant is considered healthy following physical exam. * Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits Exclusion Criteria: * Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial. * Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics). * Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery). * Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract. * Failure to thrive. * Known lactose or gluten intolerance. * Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo. * Known other causes for abdominal pain (e.g., pyloric stenosis). * Participation in any other interventional clinical study. * Immuno-compromised participant or participant with other severe chronic disorder. * Use of probiotic supplements by breastfeeding mother from child's birth to enrolment. * Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial. * Any Participant/Parent/Caregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.