Human Milk Oligosaccharide (HMO) Supplementation in Colic Management

Efficacy and Tolerability of a Composition Comprising of HMO in a Supplement Format on Colic Management: a Double-blind, Randomized, Placebo-controlled Trial

Efficacy and tolerability of a composition comprising of HMO in a supplement format on colic management: a double-blind, randomized, placebo-controlled trial

This is a double-blinded, randomized, placebo-controlled trial. The purpose of this trial is to investigate the efficacy and tolerability of a composition comprising of HMO in a supplement format in the management of colicky infants aged 2-12 weeks.

Inclusion criteria:

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

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

   1. An infant who is less than 5 months of age (in the current clinical trial, only infants 2 weeks to 8 weeks of age will be enrolled) when the symptoms start and stop
   2. Recurrent and prolonged periods of infant crying, fussing, or irritability reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers
   3. No evidence of infant failure to thrive, fever, or illness
   4. Excessive crying/fussiness for 3 or more hours per day during 3 or more days in the past 7 days as reported by parents to the clinician
   5. Total 24-hour crying plus fussing is 3 hours or more when measured by at least one prospectively kept 24-hour behavior diary. (The Structured Infant Crying and Fussing Diary will be dispensed at the screening visit (V0), completed for two 24-hour periods at H0 (days -3 to -1), and returned at V1 to be used as part of the diagnostic criteria for infantile colic.)

3. Term infants (≥ 37 weeks) generally healthy with normal birth weight (≥2.5kg) and singleton born

4. Predominantly formula fed* (formula fed ≥ 80% of the time) for at least 7 days before randomization and the choice of formula feeding has been made by the parents before the beginning of the trial.

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

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

7. Parent/LAR of infant agrees not to enroll infant in another interventional clinical research study while participating in this study

8. Parent of the infant/LAR is willing and able to fulfill the requirements of the study protocol

9. Parent of infant can be contacted throughout the study

   • Predominantly formula feeding defined in the study means that the infant's predominant source of nourishment is formula. Specifically, infants are fed with 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/infection and (or) medication use that could interfere with the main study outcomes.

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

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

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

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

   • 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.