Human Milk Oligosaccharide (HMO) Supplementation in Colic Management

Inclusion criteria:

1. Infants 2 weeks - 12 weeks of age at enrolment

2. Infants diagnosed with colic according to Rome IV criteria: Diagnostic criteria forresearch purposes (infant must meet all Rome IV criteria):

3. An infant who is less than 5 months of age (in the current clinical trial, onlyinfants 2 weeks to 8 weeks of age will be enrolled) when the symptoms start andstop

4. Recurrent and prolonged periods of infant crying, fussing, or irritabilityreported by caregivers that occur without obvious cause and cannot be preventedor resolved by caregivers

5. No evidence of infant failure to thrive, fever, or illness

6. Excessive crying/fussiness for 3 or more hours per day during 3 or more days inthe past 7 days as reported by parents to the clinician

7. Total 24-hour crying plus fussing is 3 hours or more when measured by at leastone prospectively kept 24-hour behavior diary. (The Structured Infant Cryingand Fussing Diary will be dispensed at the screening visit (V0), completed fortwo 24-hour periods at H0 (days -3 to -1), and returned at V1 to be used aspart of the diagnostic criteria for infantile colic.)

8. Term infants (≥ 37 weeks) generally healthy with normal birth weight (≥2.5kg) andsingleton born

9. Predominantly formula fed* (formula fed ≥ 80% of the time) for at least 7 daysbefore randomization and the choice of formula feeding has been made by the parentsbefore the beginning of the trial.

10. Infants who have been on the same formula for the past 5 days

11. Signed informed consent obtained for infant's and parents'/Legally AcceptableRepresentative (LAR) participation in the study

12. Parent/LAR of infant agrees not to enroll infant in another interventional clinicalresearch study while participating in this study

13. Parent of the infant/LAR is willing and able to fulfill the requirements of thestudy protocol

14. Parent of infant can be contacted throughout the study

• Predominantly formula feeding defined in the study means that the infant'spredominant source of nourishment is formula. Specifically, infants are fedwith formula for at least 80% of total milk feeds per day.

Exclusion criteria:

1. Presence of any congenital condition and/or previous or current illness/infectionand (or) medication use that could interfere with the main study outcomes.

2. Clinical evidence of chronic illness or gastrointestinal disorders, major medicalproblems (e.g. ill, immunocompromised, major developmental or genetic abnormality).

3. Known cow's milk protein allergy, lactose intolerance, or galactosaemia; includingpresence of any allergic manifestations.

4. Received any special formula (e.g. lactose-free, hydrolyzed protein) within 5 daysbefore randomization or switched formulas within 5 days before randomization.

5. Received any of the following products/medication within 5 days beforerandomization:

• Antibiotics

• Alginate

• Prokinetics

• Proton pump inhibitors

• Simethicone

• L. reuteri probiotic

• Formula containing Human milk Oligosaccharides

6. Other infant(s) <6months of age living in the same household.

7. Current participation in another interventional clinical trial.