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

Exclusion Criteria13

• 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.