Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

Eligibility 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
• * 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.