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

• Probiotic (Dietary supplement): Single strain probiotic in a form of a sachets with a daily dose of 1.0E+9 Colony Forming Unit (CFU) per day for 4 weeks
• Placebo (Dietary supplement): Placebo

Primary outcomes

• Change in cry and fuss time [Day 0, Day 28]: eDiary parent reported cry and fuss time

Secondary outcomes

• Change in cry and fuss time [Day 0, Day 7]: eDiary parent reported cry and fuss time
• Resolution of colic symptoms [Day 0, Day 28]: Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
• Change in cry and fuss time bouts [Day 0, Day 7, Day 28]: eDiary parent reported cry and fuss bouts
• Change in sleeping time [Day 0, Day 7, Day 28]: eDiary parent reported sleep time
• Change in the use of rescue medications [Day 0, Day 28]: Change in the proportion of participants needing to use rescue medications between the study arms

Other outcomes

• Change in maternal quality of life and mental health [Day 0, Day 28]: Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score)
• Change in maternal quality of life and mental health [Day 0, Day 28]: Change in maternal QoL using MAPP/QoL (improvement marked by increase in the total score)
• Resolution of colic symptoms [Day 0, Day 28]: Reduction of cry and fuss time (parent reported) greater than 50% comparing to baseline
• Change in the use of rescue medication drops [Day 0, Day 7, Day 28]: Change in the number of rescue medication drops used between the study arms
• Change in duration of daily crying and fussing episodes [Day 0, Day 7, Day 28]: Change in mean duration per crying and fussing episode per day
• Changes in gut microbiome composition [Day 0, Day 28]: Changes in microbiome composition as measured by changes in alpha and beta diversity of the gut microbiome throughout the study as compared to placebo and baseline
• Change in fecal calprotectin concentration [Day 0, Day 28]: Changes in fecal calprotectin concentration throughout the study as compared to placebo and baseline
• Adverse Events (AEs) [From enrolment to Day 35]: Reports of Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Change in vital signs [Day 0, Day 28]: Changes in vital sign measurements (heart rate \[bpm\] and body temperature \[°F\]) collected during the study will be summarised by treatment group

Sex: All, ages: 3 Weeks to 12 Weeks

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.