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

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 ≥3hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviourdiary recording >3 hours of crying in a 24-hour period (eDiary App completed dailyduring 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 motherof the infant can attend all three trial visits

Exclusion Criteria:

• Use of antibiotics by the infant within 2-weeks prior to the screening visit orduring the run-in period of the trial.

• Use of probiotic supplements from child's birth to enrolment (this includes infantformulas containing probiotics).

• Need for hospitalization (defined as readmission to a hospital ward after initialdischarge following delivery).

• Congenital disorders that, in the opinion of the investigator, would impact thegastrointestinal tract.

• Failure to thrive.

• Known lactose or gluten intolerance.

• Known allergy to cow's milk proteins, fish, or any of the substances of the trialproduct 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 toenrolment.

• Use of antibiotics by breastfeeding mother within 2-weeks prior to the screeningvisit or during the run-in period of the trial.

• Any Participant/Parent/Caregiver who is an employee of the investigational site oran Atlantia Clinical Trials employee or their close family member or a member oftheir household.