An Infant Formula Trial on Dietary Management of Infantile Colic

Inclusion Criteria:

1. Infants aged 21-56 days (both inclusive);
2. Gestation age 37-42 weeks;
3. Normal birth weight for gestational age and gender
4. 5-minute APGAR score >7;
5. Diagnosed with infantile colic ;
6. Fully formula fed for at least 7 days before randomisation;
7. Written informed consent from the parent and/or legal representative.

Exclusion Criteria:

1. Any plausible cause of inconsolable crying as judged by the investigator;
2. Presence of non-functional vomiting or failure to thrive;
3. Presence of any congenital defects in the gastrointestinal system or other defects preventing oral nutrition;
4. Congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes;
5. Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations;
6. Received any special formula (e.g. lactose-free, hydrolysed protein);

7. Received any of the following products/medication within 7 days before randomisation:

   1. Probiotics
   2. Systemic antibiotics
   3. Prokinetics
   4. Proton pump inhibitors
8. Twins or triplets or other infant(s) <6 months of age living in the same household;
9. Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
10. Current participation in another clinical study involving investigational or marketed products.